Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the colon or rectum
- Metastatic disease
- No metastases involving only the bone
- Inoperable disease (i.e., not suitable for complete surgical resection)
- Measurable or evaluable disease
- Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional CT scan OR ≥ 10 mm by spiral CT scan
- No symptomatic ascites or pleural effusion that has not been evacuated
- No CNS metastasis
PATIENT CHARACTERISTICS:
- WHO OR ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelets ≥ 100,000/mm^3
- Creatinine < 3 times upper limit of normal (ULN)
- Alkaline phosphatase < 5 times ULN
- No peripheral neuropathy ≥ grade 1
- No total or partial bowel obstruction
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled hypercalcemia
- No other concurrent or prior malignancy, except adequately treated carcinoma in situ
of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in
complete remission for ≥ 5 years
- No uncontrolled congestive heart failure
- No angina pectoris
- No hypertension
- No arrhythmias
- No history of significant neurologic or psychiatric disorders
- No active infection
- No other serious nonmalignant disease
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy and/or immunotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed provided progression-free interval after
completion of adjuvant chemotherapy is > 6 months
- No other concurrent anticancer treatment
- No participation in another clinical trial with any investigational drug within 30
days prior to randomization
- No other concurrent investigational treatment
- No concurrent radiotherapy
- No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention
of stomatitis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Aimery de Gramont, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Saint Antoine
Authority:
United States: Federal Government
Study ID:
CDR0000453890
NCT ID:
NCT00274872
Start Date:
January 2004
Completion Date:
Related Keywords:
- Colorectal Cancer
- recurrent rectal cancer
- stage IV rectal cancer
- recurrent colon cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colorectal Neoplasms
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