R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Inclusion Criteria

• Histologically or cytologically confirmed small cell lung cancer
• Extensive stage disease
• Recurrent disease
• Measurable disease
• Chemotherapy-sensitive disease, defined as:
• No progression during first-line chemotherapy
• No disease recurrence 12 weeks
• Leukocytes ≥ 3,000/μL
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin 8 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception before, during, and for 30 days after completion of study therapy
• Able to take oral medications on a regular basis
• Willing to provide blood samples for mandatory correlative studies
• No condition that impairs the ability to swallow and retain R-(-)-gossypol tablets, including the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• Active peptic ulcer disease
• No malabsorption syndrome or disease significantly affecting gastrointestinal function
• No ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction
• No uncontrolled concurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness or social situations that would limit compliance with study requirements
• No symptomatic hypercalcemia > grade 2
• No requirement for routine use of hematopoietic growth factors (including G-CSF, GM-CSF, or IL-11) or platelet transfusions to maintain ANC or platelet counts
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to R-(-)-gossypol
• No HIV positivity
• Recovered from all prior therapy, including prior surgical procedures
• No prior surgical procedures affecting absorption
• No prior resection of the stomach or small bowel
• No more than one prior chemotherapy regimen
• No prior racemic gossypol or R-(-)-gossypol
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• At least 4 weeks since prior radiotherapy, hormonal agents, or biologic response modifiers
• At least 4 weeks since prior and no concurrent investigational agents or devices
• No concurrent prophylactic hematopoietic growth factors (including filgrastim [G-CSF], sargramostim [GM-CSF], or interleukin-11 [IL-11]) during course one
• No concurrent combination antiretroviral therapy for HIV-positive patients