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

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer Read More

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 < 2 months after completion of first-line chemotherapy
• Must have received prior platinum-based chemotherapy

• No symptomatic or progressive brain metastases

  • Patients with previously treated brain metastases who are clinically and radiographically stable or improved and have been off steroids ≥ 14 days are eligible
• ECOG performance status 0-2
• Life expectancy > 12 weeks
• Leukocytes ≥ 3,000/μL
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin < 1.5 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• Hemoglobin > 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