Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment (R-(-)-Gossypol)

Sex: Female, Male

Region of Enrollment

The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:
A Complete Response (CR) requires the disappearance of all target lesions
A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements.

Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)

Estimated using the method of Kaplan-Meier.

Survival Time

Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.
Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time to Disease Progression

Duration of Response

Overall Study

Maria Q. Baggstrom, M.D.

Extensive Stage Small Cell Lung Cancer

Recurrent Small Cell Lung Cancer

R-(-)-gossypol acetic acid

pharmacological study

laboratory biomarker analysis

Mayo Clinic

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

A Phase II Study of AT-101 in Recurrent Extensive Stage Small Cell Lung Cancer

National Cancer Institute (NCI)

Patients receive oral R-(-)-gossypol twice daily on days 1-3, cisplatin IV over 60 minutes on day 1*, and etoposide IV over 30 minutes on days 1*-3. Treatment repeats every 21 days for up to 6 courses during the dose escalation and 4 courses in the expanded extensive stage small cell lung cancer cohort, in the absence of disease progression or unacceptable toxicity.
Blood samples are collected on day 1 of courses 1 and 2 for pharmacokinetic analysis, biomarker assays, and correlative studies.
After completion of study treatment, patients are followed for 30 days.
[Note: *Cisplatin and etoposide will be started on day 2 during course 1; they will be given on day 1 during all subsequent courses.]

Unspecified Adult Solid Tumor, Protocol Specific

cisplatin

etoposide

Sanford Cancer Center-Oncology Clinic

Gundersen Lutheran

UW Health Oncology - 1 South Park

University of Wisconsin Hospital and Clinics

R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer

A Phase 1 Study of R-(-)-Gossypol (AT-101) in Combination With Cisplatin and Etoposide in Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer

The 95% confidence interval will be obtained.

Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. A 95% confidence interval of the overall response rate will be constructed.

Summarized by dose level with simple summary statistics: means, medians, ranges, and standard deviations.

gossypol acetic acid/lung neoplasms

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

R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer

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