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

Inclusion Criteria

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