Breast Cancer Clinical Trial
Official title:
A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of
carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or
refractory lymphomas.
OBJECTIVES:
- Determine the maximum tolerated dose of paclitaxel when combined with
carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.
- Determine the pharmacokinetics and toxicities of this regimen in these patients.
- Identify diseases for which this combination appears active.
OUTLINE: This is a dose escalation study.
Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on
day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are
21 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who achieve complete response receive 2 additional courses of treatment.
Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel.
Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
;
Primary Purpose: Treatment
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