Colorectal CancerPhase 2NCT00066274
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study testing FOLFIRI regimen, FOLFOX regimen and fluorouracil in people with Colorectal Cancer, run by UNICANCER at 17 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFIRI regimen, FOLFOX regimen and fluorouracil
- How many people
- Not given
- Where
- 17 sitesFrance
- Study dates
- 23 Jul 2002to 1 Apr 2007
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal carcinoma
- Metastatic disease
- Not amenable to surgery
- Unidimensionally measurable disease
- No bone metastases
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present)
- SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present)
Renal
- Creatinine no greater than 1.25 times ULN
Cardiac
- No concurrent cardiac abnormalities that would preclude study therapy
Pulmonary
- No concurrent pulmonary abnormalities that would preclude study therapy
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No chronic enteropathy
- No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer
- No concurrent severe uncontrolled infection
- No obstruction or partial obstruction that would interfere with study therapy
- No psychological, social, familial, or geographical situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biological response modifiers
Chemotherapy
- No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago)
- No prior irinotecan
- No prior oxaliplatin
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
Radiotherapy
- At least 4 weeks since prior pelvic radiotherapy
- No prior abdominopelvic radiotherapy
Surgery
- At least 4 weeks since prior surgery
- No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines)
Other
- No other concurrent experimental medication
- No other concurrent anticancer therapy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Centre Hospitalier de L' Agglomeration Montargoise
Amilly, 45207
Pole Sante Sarthe et Loir Hopital Pierre Daguet
Angers, 49036
Institut Bergonie
Bordeaux, 33076
Centre Regional Francois Baclesse
Caen, 14076
Clinique Sainte-Marguerite
Hyères, 83400
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025
Centre Oscar Lambret
Lille, 59020
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
CHR D'Orleans - Hopital de la Source
Orléans, 45100
Polyclinique Francheville
Périgueux, 24004
Centre Eugene Marquis
Rennes, 35062
CHG Roanne
Roanne, F-42300
Centre Hospitalier de Rodez
Rodez, 12027
Centre Rene Huguenin
Saint-Cloud, 92210
Centre Hospitalier Regional Metz Thionville
Thionville, 57126
Centre Hospitalier General Lucien Hussel
Vienne, 38200
About this study
Official title: Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
- Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
- Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI regimen, FOLFOX regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium
- Keywords
- stage IV colon cancer, stage IV rectal cancer
- 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.
FOLFIRI regimenDrug
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 Aug 2003 (estimated)
- Study start23 Jul 2002
- Primary completion4 Nov 2005
- Study completion1 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Becouarn, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066274
- Sponsor's protocol ID
- Accord 08
- Other IDs
- FRE-FNCLCC-ACCORD-08/0103, EU-20233
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2003
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4.
PubMed 17785765
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00066274
- Acronym / sponsor ID
- Accord 08
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 23 Jul 2002 (actual)
- Primary completion
- 4 Nov 2005 (actual)
- Study completion
- 1 Apr 2007 (actual)
- First posted
- 7 Aug 2003 (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. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
Detailed description
OBJECTIVES:
- Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
- Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- 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 |
|---|---|---|
| FOLFIRI regimen | Drug | – |
| FOLFOX regimen | Drug | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | 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 2 Mar 2021.
- Results publication: PubMed 17785765Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4.
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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.
Yves Becouarn, MD study chair
Institut Bergonié
17 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 FOLFIRI regimen, FOLFOX regimen and fluorouracil in people with Colorectal Cancer, run by UNICANCER at 17 sites in France.
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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
On the ClinicalTrials.gov record for NCT00066274, which also lists 1 linked publication.
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 2 Mar 2021.