Clinical Trials Directory

Trials / Completed

CompletedNCT00891072

Gossypol, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

A Phase 1 Study of R-(-)-Gossypol (Ascenta's AT-101) in Combination With Paclitaxel and Carboplatin in Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
36 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of gossypol when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy, such as gossypol, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gossypol together with paclitaxel and carboplatin may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: I. The primary end point will be to determine the maximum tolerated dose of AT-101 with paclitaxel and carboplatin. SECONDARY OBJECTIVES: I. To describe the toxicities associated with the combination of paclitaxel, carboplatin, and AT-101. II. To evaluate the human pharmacokinetic disposition of AT-101 in the context of escalating doses. III. To describe the pharmacokinetics of paclitaxel when given concurrently with AT-101. IV. To evaluate for evidence of activity for the combination of paclitaxel, carboplatin and AT-101. OUTLINE: This is a dose-escalation study of R-(-)-gossypol acetic acid. Patients receive oral R-(-)-gossypol acetic acid twice daily on days 1-3. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies by liquid chromatography/mass spectrometry. After completion of study therapy, patients are followed for 4 weeks.

Conditions

Interventions

TypeNameDescription
DRUGR-(-)-gossypol acetic acidGiven orally
DRUGpaclitaxelGiven IV
DRUGcarboplatinGiven IV
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2009-07-01
Primary completion
2011-04-01
Completion
2011-04-01
First posted
2009-04-30
Last updated
2013-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00891072. Inclusion in this directory is not an endorsement.