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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041054 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: etoposide Drug: exisulind |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer |
| Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study within 8 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 unidimensionally measurable lesion
Lesions considered nonmeasurable include:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal agents except:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 83 Study Locations| Study Chair: | Ramaswamy Govindan, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
| Study ID Numbers: | CDR0000069439, CLB-30104 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041054 History of Changes |
| Health Authority: | United States: Federal Government |
|
extensive stage small cell lung cancer |
|
Anti-Inflammatory Agents Anticarcinogenic Agents Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Etoposide phosphate Neoplasms by Site Respiratory Tract Diseases Sensory System Agents Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Carboplatin Protective Agents Sulindac sulfone Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors |