Colorectal Cancer Clinical Trial
Official title:
Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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