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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Acetic Acid; Gossypol; Gossypol acetic acid; Retinol acetate

Criteria

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