Colorectal CancerPhase 2NCT00016198
Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Prologue Research International at 74 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX regimen, fluorouracil and leucovorin calcium
- How many people
- Not given
- Where
- 74 sitesUnited States
- Study dates
- May 2001to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) Documented sequential disease progression (by CT scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy for metastatic disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesion unless documented progression within the radiation portal Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary tumor or metastases and recovered Other: No prior investigational anticancer drug No other concurrent investigational agents
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
Dreyer Medical Clinic
Aurora, Illinois, 60506
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70821-2511
Bend Memorial Clinic
Bend, Oregon, 97701
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem, Pennsylvania, 18015
Deaconess Billings Clinic
Billings, Montana, 59107-5100
Center for Hematology-Oncology
Boca Raton, Florida, 33486
HemOnCare, P.C.
Brooklyn, New York, 11235
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, 37404
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
Family Cancer Center
Collierville, Tennessee, 38017
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
Citrus Valley Medical Center
Covina, California, 92807
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
Halifax Medical Center
Daytona Beach, Florida, 32114
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50309
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
Florida Cancer Specialists
Fort Myers, Florida, 33901
California Cancer Care, Inc.
Greenbrae, California, 94904
Medical Oncology Group
Gulfport, Mississippi, 39501
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Hematology/Oncology Associates
Jacksonville, Florida, 32216
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
Lake Heart and Cancer Medical Center
Leesburg, Florida, 34748
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kenmar Research Institute
Los Angeles, California, 90057
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Saints Memorial Medical Center
Lowell, Massachusetts, 01852
Reddy Cancer Treatment Center
Malone, New York, 12953
Mercy Cancer Center
Mason City, Iowa, 50401
West Cancer Clinic
Memphis, Tennessee, 38120
Cancer and Blood Institute
Metairie, Louisiana, 70006
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
Jersey Shore Cancer Center
Neptune City, New Jersey, 07753
Central Jersey Oncology Center
New Brunswick, New Jersey, 08901
New York University Medical Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19107
Arkansas Cancer Clinic, P.A.
Pine Bluff, Arkansas, 71603
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
Hematology Associates of New Jersey, P.A.
Ridgewood, New Jersey, 07450
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
University of Rochester Medical Center
Rochester, New York, 14642
South Shore Hematology Oncology Associates, P.C.
Rockville Centre, New York, 11570
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64506
Salem Hospital Regional Cancer Center
Salem, Oregon, 97309-5014
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
Cancer Therapy and Research Center
San Antonio, Texas, 78229
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Scott and White Memorial Hospital
Temple, Texas, 76508
Hope Center
Terre Haute, Indiana, 47809
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
Arizona Clinical Research Center
Tucson, Arizona, 85712
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
New York Medical College
Valhalla, New York, 10595
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
John Muir Medical Center
Walnut Creek, California, 94598
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch, New Jersey, 07764
Lawrence M. Stallings Medical Practice
Wooster, Ohio, 44691
About this study
Official title: A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Read the detailed description
OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX regimen, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
fluorouracilDrug
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2004 (estimated)
- Study startMay 2001
- Primary completionApr 2003
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Prologue Research International
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard A. Gams, MD, Study chair, Prologue Research International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016198
- Sponsor's protocol ID
- PROLOGUE-EFC4760
- Other IDs
- CDR0000068606, SANOFI-EFC4760
- Status last verified
- Dec 2010
- First submitted
- 6 May 2001
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00016198
- Acronym / sponsor ID
- PROLOGUE-EFC4760
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Prologue Research InternationalIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| FOLFOX regimen | Drug | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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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.
Richard A. Gams, MD study chair
Prologue Research International
74 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Prologue Research International at 74 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 26 Jun 2013.