Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
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.
|Brain and Central Nervous System Tumors Breast Cancer Kidney Cancer Lung Cancer Lymphoma Melanoma (Skin) Ovarian Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: carboxyamidotriazole Drug: paclitaxel||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA|
|Study Start Date:||October 1994|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019019
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Medical Oncology Clinical Research Unit|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Virginia Kwitkowski, MS, RN, CS, CRNP||National Cancer Institute (NCI)|