R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00773955
- Run by
- National Cancer Institute (NCI)
- People needed
- 15
- Starts
- 2008-11-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2014-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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