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

NCT00773955 | Completed Phase 2 Results

• 8 other identifiers: NCI-2009-01058MAYO-MC0721CDR0000616965MC07218027N01CM62205P30CA015083N01CM62209
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  During the first 6 courses of treatment

Secondary Outcomes (3)

• Survival Time

  From registration to death due to any cause, assessed up to 5 years

• Time to Disease Progression

  From registration to the earliest date documentation of disease progression, assessed up to 5 years

• Duration of Response

  From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years

Study Arms (1)

Treatment (R-(-)-gossypol)

EXPERIMENTAL

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.

Drug: R-(-)-gossypol acetic acid; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

R-(-)-gossypol acetic acid DRUG

Given orally

Also known as: AT-101

Treatment (R-(-)-gossypol)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (R-(-)-gossypol)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (R-(-)-gossypol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Maria Q. Baggstrom, M.D.
• Organization: Washington University

Mbaggstr@im.wustl.edu

Study Officials

• Maria Baggstrom

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: August 1, 2010
• Last Updated: May 12, 2014
• Results First Posted: March 21, 2013

Record last verified: 2011-10

Locations

US (1)