Colorectal NeoplasmsPhase 3NCT00101686

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

A Phase 3 study testing Modified Bolus 5-FU/LV with Irinotecan, FOLFIRI + bevacizumab and miFL + bevacizumab in people with Colorectal Neoplasms, run by Pfizer at 175 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and leucovorin [LV] with infusional… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Neoplasms
What is being tested?: Modified Bolus 5-FU/LV with Irinotecan, FOLFIRI + bevacizumab and miFL + bevacizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 547 participants
Where: 175 sitesin 4 countries
Study dates: Feb 2003to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
The primary cancer was a Duke's A or B1.
Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.

Who cannot join

Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
Patients cannot have concurrent malignancies at study entry.
Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.

Trial locations and contacts

175 sites in 4 countries.

Country

City, postcode or hospital

175 sites in 4 countries

United States141 sites

Pfizer Investigational Site
Abilene, Texas, 79606-5208
Pfizer Investigational Site
Abington, Pennsylvania, 19001
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Alexandria, Louisiana, 71301
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Annapolis, Maryland, 21401
Pfizer Investigational Site
Arlington, Texas, 76012
Pfizer Investigational Site
Arroyo Grande, California, 93420
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78731
Pfizer Investigational Site
Bangor, Maine, 04401
Pfizer Investigational Site
Bartlesville, Oklahoma, 74006
Pfizer Investigational Site
Beaumont, Texas, 77702-1449
Pfizer Investigational Site
Bedford, Texas, 76022
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Birmgingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmngham, Alabama, 35211
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Boulder, Colorado, 80304
Pfizer Investigational Site
Burlington, Massachusetts, 01805
Pfizer Investigational Site
Burnsville, Minnesota, 55337
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Colchester, Vermont, 05446
Pfizer Investigational Site
Collierville, Tennessee, 38017
Pfizer Investigational Site
Columbia, Missouri, 65201
Pfizer Investigational Site
Columbia, Missouri, 65203
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Dallas, Texas, 75230-2510
Pfizer Investigational Site
Dallas, Texas, 75231-4400
Pfizer Investigational Site
Dallas, Texas, 75237
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dayton, Ohio, 45409
Pfizer Investigational Site
Denton, Texas, 76210
Pfizer Investigational Site
Edmonds, Washington, 98026
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
El Paso, Texas, 79915
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fairfax, Virginia, 22031
Pfizer Investigational Site
Farmington, New Mexico, 87401
Pfizer Investigational Site
Fayetteville, North Carolina, 28302-2000
Pfizer Investigational Site
Fishers, Indiana, 46038
Pfizer Investigational Site
Flagstaff, Arizona, 86001
Pfizer Investigational Site
Fort Wayne, Indiana, 46815
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fountian Valley, California, 92708
Pfizer Investigational Site
Fredericksburg, Texas, 78624-3847
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Garland, Texas, 75042
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Glendale, Wisconsin, 53212
Pfizer Investigational Site
Grand Rapids, Michigan, 49603
Pfizer Investigational Site
Greensboro, North Carolina, 27403
Pfizer Investigational Site
Hendersonville, North Carolina, 28791
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Hooksett, New Hampshire, 03106
Pfizer Investigational Site
Hot Spring, Arkansas, 71913
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Irving, Texas, 75061-224
Pfizer Investigational Site
Jackson, Tennessee, 38301
Pfizer Investigational Site
Joplin, Missouri, 64804
Pfizer Investigational Site
Knoxville, Tennessee, 37916
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Lacy, Washington, 98503
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Lauderhill, Florida, 33319
Pfizer Investigational Site
Lebanon, New Hampshire, 03756-0001
Pfizer Investigational Site
Lewisville, Texas, 75067
Pfizer Investigational Site
Longview, Texas, 75601
Pfizer Investigational Site
Los Gatos, California, 95032
Pfizer Investigational Site
Macon, Georgia, 31201
Pfizer Investigational Site
Manhaset, New York, 11030
Pfizer Investigational Site
McAllen, Texas, 78503
Pfizer Investigational Site
Mesquite, Texas, 75050
Pfizer Investigational Site
Miami, Florida, 33133
Pfizer Investigational Site
Miami Beach, Florida
Pfizer Investigational Site
Midland, Texas, 79701
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Mission Hills, California, 91345
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Modesto, California, 95355
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
New Braunfels, Texas, 78130
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Niles, Illinois, 60714
Pfizer Investigational Site
Norman, Oklahoma, 73071
Pfizer Investigational Site
Norwalk, Connecticut, 06581
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Odessa, Texas, 79761
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Oxnard, California, 93030
Pfizer Investigational Site
Paris, Texas, 75460
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19014-4283
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Portland, Oregon, 97213
Pfizer Investigational Site
Reading, Pennsylvania, 19603
Pfizer Investigational Site
Roanoke, Virginia, 24014
Pfizer Investigational Site
Robbinsdale, Minnesota, 55422
Pfizer Investigational Site
Rockford, Illinois, 61108-2472
Pfizer Investigational Site
Rockville Centre, New York, 11570
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Jose, California, 95125
Pfizer Investigational Site
Santa Fe, New Mexico, 87501
Pfizer Investigational Site
Sarasota, Florida, 34239
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
Sedona, Arizona, 86336
Pfizer Investigational Site
Sherman, Texas, 75090-0504
Pfizer Investigational Site
Shrevport, Louisiana, 71101
Pfizer Investigational Site
Skokie, Illinois, 60077
Pfizer Investigational Site
Spokane, Washington, 99202
Pfizer Investigational Site
Springdale, Arkansas, 72764
Pfizer Investigational Site
St Louis, Missouri, 63136
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Stamford, Connecticut, 06902-3628
Pfizer Investigational Site
Summit, New Jersey, 07901
Pfizer Investigational Site
Tamarac, Florida, 33321
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tyler, Texas, 75701-2001
Pfizer Investigational Site
Tyler, Texas, 75702
Pfizer Investigational Site
Waco, Texas, 76712
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Webster, Texas, 77598
Pfizer Investigational Site
Wichita Falls, Texas, 76310
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Pfizer Investigational Site
Yakima, Washington, 98902

Other trials in United States

Canada24 sites

Pfizer Investigational Site
Brampton, Ontario, L6W 3X4
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Kingston, Ontario, K7L 5P9
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G3
Pfizer Investigational Site
Laval, Quebec, H7M 3L9
Pfizer Investigational Site
Mississauga, Ontario, L5B 1B8
Pfizer Investigational Site
Moncton, New Brunswick, E1C 8X3
Pfizer Investigational Site
Montreal, Quebec, H1T 4B3
Pfizer Investigational Site
Montreal, Quebec, H2W 1S6
Pfizer Investigational Site
Montreal, Quebec, H2X 3J4
Pfizer Investigational Site
Newmarket, Ontario, L3Y 2P9
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
Pfizer Investigational Site
Ottawa, Ontario, K1H 1C4
Pfizer Investigational Site
Québec, Quebec
Pfizer Investigational Site
Regina, Saskatchewan, S4T 7T1
Pfizer Investigational Site
Rimouski, Quebec, G5L 5T1
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 4H4
Pfizer Investigational Site
Scarborough Village, Ontario, M1P 2V5
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V76
Pfizer Investigational Site
Sydney, Nova Scotia, B1P 1P3
Pfizer Investigational Site
Thunder Bay, Ontario, P7A 7T1
Pfizer Investigational Site
Windsor, Ontario, N8W 2X3

Other trials in Canada

Australia6 sites

Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Frankston, Victoria, 3199
Pfizer Investigational Site
South Brisbane, Queensland, 4101
Pfizer Investigational Site
Waratah, New South Wales, 2298
Pfizer Investigational Site
Woodville, South Australia, 5011

Other trials in Australia

New Zealand4 sites

Pfizer Investigational Site
Auckland, 1
Pfizer Investigational Site
Dunedin, 9001
Pfizer Investigational Site
Riccarton, 8020
Pfizer Investigational Site
Wellington, 6039

Other trials in New Zealand

About this study

Official title: A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab

Conditions: Colorectal Neoplasms
Being tested: Modified Bolus 5-FU/LV with Irinotecan, FOLFIRI + bevacizumab, miFL + bevacizumab, Infusional 5-FU/LV with Irinotecan, Oral Capecitabine with Irinotecan
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Bolus 5-FU/LV with IrinotecanDrug
Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
FOLFIRI + bevacizumabDrug
Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks
miFL + bevacizumabDrug
Day 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks
Infusional 5-FU/LV with IrinotecanDrug
Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Oral Capecitabine with IrinotecanDrug
Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).

Study groups in NCT00101686
Study group	Role	What they receive
Modified Bolus 5-FU/LV with Irinotecan	Experimental	Not described Receives: Drug: Modified Bolus 5-FU/LV with Irinotecan
FOLFIRI + bevacizumab	Experimental	Not described Receives: Drug: FOLFIRI + bevacizumab
miFL + bevacizumab	Experimental	Not described Receives: Drug: miFL + bevacizumab
Infusional 5-FU/LV with Irinotecan	Experimental	Not described Receives: Drug: Infusional 5-FU/LV with Irinotecan
Oral Capecitabine with Irinotecan	Other	Not described Receives: Drug: Oral Capecitabine with Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Measured: every 6 weeks until disease progression

Secondary outcomes (13)

Time to Progression: FOLFIRI, mIFL and CapeIRI
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Measured: every 6 weeks until disease progression
Overall Response: FOLFIRI, mIFL and CapeIRI
A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )
Measured: every 6 weeks during chemotherapy until disease progression
Survival Time: FOLFIRI, mIFL and CapeIRI
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Measured: assessed at least every week during treatment and at least every 3 months during follow-up
1 Year Survival: FOLFIRI, mIFL and CapeIRI
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Measured: 1 year from date of randomization
Time to Progression : Celecoxib and Placebo
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Measured: every 6 weeks until disease progression
Overall Response: Celecoxib and Placebo
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Measured: every 6 weeks during chemotherapy until disease progression
Survival Time: Celecoxib and Placebo
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Measured: assessed at least every week during treatment and at least every 3 months during follow-up
Time to Progression: Bevacizumab With FOLFIRI, mIFL
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Measured: every 6 weeks until disease progression
Overall Response: Bevacizumab With FOLFIRI, mIFL
A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Measured: every 6 weeks during chemotherapy until disease progression
1 Year Survival: Bevacizumab With FOLFIRI, mIFL
Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Measured: 1 year from date of randomization
Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.
Measured: Last Follow-Up Visit
Dose Reduction Due to Treatment Emergent Adverse Events
Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.
Measured: Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
Overall Relative Dose Intensity of Irinotecan
Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)
Measured: End of treatment cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2003Oct 2008

First posted13 Jan 2005 (estimated)
Study startFeb 2003
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 547 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00101686
Sponsor's protocol ID: CPTAIV-0020-411
Other IDs: A5961021
Status last verified: Jan 2010
First submitted: 12 Jan 2005
Last updated: 12 Jan 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab
ClinicalTrials.gov ID: NCT00101686
Acronym / sponsor ID: CPTAIV-0020-411
Conditions: Colorectal Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 547 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2003
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 13 Jan 2005 (estimated)
Results: Posted 26 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Modified Bolus 5-FU/LV with Irinotecan	Experimental	Drug: Modified Bolus 5-FU/LV with Irinotecan
FOLFIRI + bevacizumab	Experimental	Drug: FOLFIRI + bevacizumab
miFL + bevacizumab	Experimental	Drug: miFL + bevacizumab
Infusional 5-FU/LV with Irinotecan	Experimental	Drug: Infusional 5-FU/LV with Irinotecan
Oral Capecitabine with Irinotecan	Other	Drug: Oral Capecitabine with Irinotecan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
The primary cancer was a Duke's A or B1.
Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.

Key exclusion criteria (3 listed)

Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
Patients cannot have concurrent malignancies at study entry.
Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Modified Bolus 5-FU/LV with IrinotecanDay 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID [two times a day] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).	Drug	Modified Bolus 5-FU/LV with Irinotecan
FOLFIRI + bevacizumabDay 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID [two times a day] oral Every 2 weeks	Drug	FOLFIRI + bevacizumab
miFL + bevacizumabDay 1 Bevacizumab 7.5mg/kg IV *over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID [two times a day] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID [two times a day] continues daily without interruption Every 3 weeks	Drug	miFL + bevacizumab
Infusional 5-FU/LV with IrinotecanDay 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID [two times a day](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).	Drug	Infusional 5-FU/LV with Irinotecan
Oral Capecitabine with IrinotecanDay 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID [two times a day] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).	Drug	Oral Capecitabine with Irinotecan

Primary outcome

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
Time frame: every 6 weeks until disease progression
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).

13 secondary outcomes

Time to Progression: FOLFIRI, mIFL and CapeIRI
Time frame: every 6 weeks until disease progression
Overall Response: FOLFIRI, mIFL and CapeIRI
Time frame: every 6 weeks during chemotherapy until disease progression
Survival Time: FOLFIRI, mIFL and CapeIRI
Time frame: assessed at least every week during treatment and at least every 3 months during follow-up
1 Year Survival: FOLFIRI, mIFL and CapeIRI
Time frame: 1 year from date of randomization
Time to Progression : Celecoxib and Placebo
Time frame: every 6 weeks until disease progression
Overall Response: Celecoxib and Placebo
Time frame: every 6 weeks during chemotherapy until disease progression
Survival Time: Celecoxib and Placebo
Time frame: assessed at least every week during treatment and at least every 3 months during follow-up
Time to Progression: Bevacizumab With FOLFIRI, mIFL
Time frame: every 6 weeks until disease progression
Overall Response: Bevacizumab With FOLFIRI, mIFL
Time frame: every 6 weeks during chemotherapy until disease progression
1 Year Survival: Bevacizumab With FOLFIRI, mIFL
Time frame: 1 year from date of randomization
Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
Time frame: Last Follow-Up Visit
Dose Reduction Due to Treatment Emergent Adverse Events
Time frame: Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
Overall Relative Dose Intensity of Irinotecan
Time frame: End of treatment cycle

Results and safety

Results posted to the registry on 26 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FOLFIRI + Celecoxib	71	0
FOLFIRI + Placebo	73	0
mIFL + Celecoxib	69	0
mIFL + Placebo	72	0
CapeIRI + Celecoxib	73	0
CapeIRI + Placebo	72	0
Bevacizumab + FOLFIRI + Celecoxib	27	0
Bevacizumab + FOLFIRI + Placebo	30	0
Bevacizumab + mIFL + Celecoxib	30	0
Bevacizumab + mIFL + Placebo	30	0

Primary outcome: Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL

Time frame: every 6 weeks until disease progression. Median (95% Confidence Interval). Unit: months

Measure	FOLFIRI n = 144	mIFL n = 141
Value	8.18 (7.43 to 8.97)	6.01 (5.52 to 7.03)

FOLFIRI vs mIFL: Hazard Ratio (HR): 1.433 (95% CI 1.09 to 1.89), p = 0.0152, Log Rank

Population analysed: Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FOLFIRI	50 of 137 (36.5%)	135 of 137 (98.5%)	Not reported
mIFL	52 of 137 (38%)	137 of 137 (100%)	Not reported
CapeIRI	78 of 141 (55.3%)	140 of 141 (99.3%)	Not reported
Bevacizumab + FOLFIRI	19 of 56 (33.9%)	56 of 56 (100%)	Not reported
Bevacizumab + mIRI	21 of 59 (35.6%)	58 of 59 (98.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

175 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Modified Bolus 5-FU/LV with Irinotecan, FOLFIRI + bevacizumab and miFL + bevacizumab in people with Colorectal Neoplasms, run by Pfizer at 175 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL (time frame: every 6 weeks until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.