Phase I Study of PS-341 (VELCADE) in Combination With 5FU/LV Plus Oxaliplatin in Patients With Advanced Colorectal Cancer
- Determine the dose-limiting toxicity and maximum tolerated dose of bortezomib when
administered with fluorouracil, leucovorin calcium, and oxaliplatin in patients with
advanced or metastatic colorectal cancer.
- Determine the recommended phase II dose of bortezomib in patients treated with this
- Determine response in patients with measurable disease treated with this regimen.
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of
Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15; oxaliplatin IV over 2
hours on days 1 and 15; and leucovorin calcium IV over 2 hours and fluorouracil IV over 22
hours on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Additional patients receive treatment at
the MTD to a maximum of 12 patients at that dose level.
Patients are followed every 8 weeks until disease progression or start of a new anticancer
PROJECTED ACCRUAL: Not specified.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended dose of bortezomib as measured by CTC v3.0
Francesco Caponigro, MD
Istituto Nazionale per lo Studio e la Cura dei Tumori
United States: Federal Government