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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: | NCT00042978 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen may increase the effectiveness of carboplatin and etoposide by making tumor cells more sensitive to the drugs.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without oblimersen in treating patients who have extensive-stage small cell lung cancer.
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: carboplatin Drug: etoposide Drug: oblimersen |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Carboplatin Etoposide Etoposide phosphate Oblimersen sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 (NSC #683428, IND #58842) In Patients With Extensive Stage Small Cell Lung Cancer |
| Study Start Date: | April 2003 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients (41 for arm I and 14 for arm II) will be accrued for this study within 11 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other concurrent active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations![]() |
Show 47 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Ravi Salgia, MD, PhD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Rudin CM, Salgia R, Wang X, Hodgson LD, Masters GA, Green M, Vokes EE. Randomized phase II Study of carboplatin and etoposide with or without the bcl-2 antisense oligonucleotide oblimersen for extensive-stage small-cell lung cancer: CALGB 30103. J Clin Oncol. 2008 Feb 20;26(6):870-6.
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Rudin CM, Salgia R, Wang XF, et al.: CALGB 30103: a randomized phase II study of carboplatin and etoposide (CE) with or without G3139 in patients with extensive stage small cell lung cancer (ES-SCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7168, 662s, 2005.
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| Study ID Numbers: | CDR0000069489, CALGB-30103 |
| First Received: | August 5, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00042978 |
| Health Authority: | United States: Federal Government |
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