Status:
COMPLETED
R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the objective response rate of R-(-)-gossypol in patients with recurrent chemotherapy-sensitive extensive stage small cell lung cancer. II. To determine the time ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00773955
Start Date
November 1 2008
End Date
August 1 2010
Last Update
May 12 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905