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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544596 |
RATIONALE: Gossypol may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gossypol together with combination chemotherapy may help kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gossypol when given together with cisplatin and etoposide in treating patients with advanced solid tumors or extensive stage small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: R-(-)-gossypol acetic acid Drug: cisplatin Drug: etoposide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 34 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of R-(-)-gossypol.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Patients with small cell lung carcinoma and brain metastases should have stable/improved lesions for at least 1 month following treatment, no neurological symptoms, and no requirement for corticosteroids
PATIENT CHARACTERISTICS:
Inclusion criteria
Exclusion criteria
Uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria
Exclusion criteria
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 |
Principal Investigator: | George Wilding, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000570006, WCCC-CO-07901 |
Study First Received: | October 13, 2007 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00544596 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Contraceptive Agents Contraceptive Agents, Female Contraceptive Agents, Male Gossypol acetic acid Etoposide phosphate Gossypol Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Retinol acetate Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Carcinoma, Neuroendocrine Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Etoposide phosphate Gossypol Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms |
Neoplasms, Germ Cell and Embryonal Therapeutic Uses Antispermatogenic Agents Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type Gossypol acetic acid Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases |