Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1 Study of R-(-)-Gossypol (Ascenta's AT-101) in Combination With Paclitaxel and Carboplatin in Solid Tumors
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
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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