A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
- 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
Virginia Kwitkowski, MS, RN, CS, CRNP
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Medical Oncology Clinical Research Unit||Bethesda, Maryland 20892|