Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00274872
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Compare progression-free survival of patients with inoperable metastatic colorectal cancer treated with oxaliplatin, leucovorin calcium, and fluorouracil with vs without maintenance leucovorin calcium and fluorouracil.
* Demonstrate that time of disease control (TDC) can be increased by 15% at 9 months and that maintenance therapy can be avoided.
Secondary
* Compare the overall survival and response rate in patients treated with these regimens.
* Compare the salvage surgery rate in patients treated with these regimens.
* Compare the tolerability of these regimens in these patients.
* Compare the quality of life in patients treated with these regimens.
* Compare the duration of chemotherapy-free intervals in patients treated with these regimens.
* Compare the pharmacoeconomy and pharmacogenetics of these regimens in these patients.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), number of metastatic sites (1 vs \> 1), age (18-50 years vs 51-75 years vs 76-80 years), adjuvant chemotherapy, and baseline alkaline phosphatase (≤ 3 times upper limit of normal \[ULN\] vs \> 3 times ULN). Patients are randomized to 1 of 2 treatment arms.
Arm I
* FOLFOX chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance chemotherapy.
* Maintenance chemotherapy: Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients with disease progression on maintenance chemotherapy receive 6 additional courses of FOLFOX as above. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.
Arm II
* FOLFOX chemotherapy: Patients receive 6 courses of FOLFOX as in arm I. Patients with disease progression on FOLFOX receive 6 additional courses of FOLFOX. Patients with continued disease progression while receiving the additional courses of FOLFOX proceed to irinotecan-based chemotherapy off study.
In both arms, patients with stable or responding disease may undergo surgical resection after completion of the initial 6 courses of FOLFOX.
Quality of life is assessed at baseline, after courses 4 and 6, and then every 2-3 months thereafter.
After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival Toxicity Response as measured by RECIST criteria Time to disease control Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment Pharmaco-economic evaluation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Centre Hospitalier de Dreux
🇫🇷Dreux, France
Hopital Louis Pasteur - Le Coudray
🇫🇷Le Coudray, France
Institut Sainte Catherine
🇫🇷Avignon, France
Infirmerie Protestante
🇫🇷Caluire, France
Hopital Duffaut
🇫🇷Avignon, France
Hopital Drevon
🇫🇷Dijon, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Hopital Robert Boulin
🇫🇷Libourne, France
Clinique Saint Jean
🇫🇷Lyon, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
C.H. Senlis
🇫🇷Senlis, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France
Clinique des Jockeys
🇫🇷Senlis, France
Polyclinique De Courlancy
🇫🇷Reims, France
Intercommunal Hospital
🇫🇷Montfermeil, France