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| Sponsors and Collaborators: |
Cancer and Leukemia Group B 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 |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Carboplatin Etoposide Etoposide phosphate Sulindac sulfone |
| 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 |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Ramaswamy Govindan, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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Wang XF, Govindan R, Herndon JE, et al.: A phase II study of carboplatin, etoposide and exisulind in patients with extensive stage small cell lung cancer: CALGB 30104. [Abstract] J Clin Oncol 23 (Suppl 16): A-7161, 660s, 2005.
  |
| Study ID Numbers: | CDR0000069439, CLB-30104 |
| First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00041054 |
| Health Authority: | United States: Federal Government |
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