Gastrointestinal Cancer Clinical Trial
Official title:
Phase II Trial of Oxaliplatin in Combination With Bolus/Infusional 5FU/LV (FOLFOX4) in Patients With Advanced Gastrointestinal (GI) Cancers With Varying Degrees of Renal Impairment
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies
who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal
dysfunction) based on their baseline measured creatinine clearance then treated with
FOLFOX4.
Standard bone marrow and liver function inclusion and exclusion criteria must be met prior
to study treatment. FOLFOX4 in the study is given every 2 weeks (1 cycle = 2 weeks) for up
to 12 cycles unless there are treatment delays to allow for recovery from toxic effects.
Dose modifications are included for protocol specified toxicities. After 12 treatment cycles
on study, patients who are having a beneficial disease response may continue to have
oxaliplatin supplied off study to continue the treatment regimen until disease progression,
prohibitive toxicity or death.
Oxaliplatin pharmacokinetic studies (plasma and urine) are planned during cycles 1 and 2 on
each patient. Creatinine clearance will be assessed every 2 cycles and disease status will
be assessed every 3 cycles of treatment during the study.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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