Trials / Completed
CompletedNCT00019019
Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- National Institutes of Health Clinical Center (CC) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboxyamidotriazole | |
| DRUG | paclitaxel |
Timeline
- Start date
- 1994-10-01
- Primary completion
- 2006-07-01
- Completion
- 2006-07-01
- First posted
- 2003-01-27
- Last updated
- 2012-03-15
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00019019. Inclusion in this directory is not an endorsement.