The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Local Institution
Saint-Herblain, France
Local Institution
Villejuif, France
Safety assessment
Time frame: throughout the study
dose-limiting toxicity (DLT)
Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Describe anti-tumor of combination therapy
Time frame: Every 8 weeks throughout the study
Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples
Time frame: throughtout the study
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