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

OBJECTIVES:

Primary

- To determine the maximum-tolerated dose of R-(-)-gossypol acetic acid in combination
with paclitaxel and carboplatin in patients with metastatic or unresectable solid
tumors.

Secondary

- To describe the toxicities associated with the combination of paclitaxel, carboplatin,
and R-(-)-gossypol acetic acid in these patients.

- To evaluate the human pharmacokinetic disposition of R-(-)-gossypol acetic acid in the
context of escalating doses.

- To describe the pharmacokinetics of paclitaxel when given concurrently with
R-(-)-gossypol acetic acid.

- To evaluate for evidence of activity for the combination of paclitaxel, carboplatin,
and R-(-)-gossypol acetic acid.

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.