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

Exclusion Criteria

• •Treatment with chemotherapy, hormonal agents (except LHRH agonists/antagonists) used for their anti-cancer activity, or biologic response modifiers within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
• •Failure to recover fully (as judged by the investigator) from prior surgical procedures, or failure to recover from adverse events due to agents administered more than 4 weeks earlier
• •Concurrent treatment with an investigational agent other than the investigational agent(s) used in this study OR treatment within 4 weeks of study entry with any investigational agent(s) or device(s)
• •Any prior use of racemic gossypol or AT-101
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to AT-101 or other agents used in study
• •Requirement for routine use of hematopoietic growth factors (including granulocyte colony stimulating factor, granulocyte macrophage colony stimulating factor, or interleukin-11) or platelet transfusions to maintain absolute neutrophil counts or platelets counts above the required thresholds for study entry; use of erythropoietin stimulating agents and RBCs prior to study enrollment is allowed
• •Neuropathy is a well described side effect of paclitaxel and carboplatin; patients may not have baseline peripheral neuropathy \>= Grade 2
• •Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain AT-101 tablets
• •Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel within the last three months are excluded; subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would affect safety or limit compliance with study requirements
• •Pregnant women are excluded from this study because the effects of AT-101 on the developing human fetus are unknown, but could potentially include teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AT-101, breastfeeding should be discontinued if the mother is treated with AT-101; these potential risks may also apply to other agents used in this study
• •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AT-101 or other agents used in this study; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• •Patients with \> grade 2 symptomatic hypercalcemia
• •Patients with a myocardial infarction (MI) or cardiac (heart) surgery within the past 3 months