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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 11, 2001 | ||||||||
| Last Updated Date | August 21, 2009 | ||||||||
| Start Date ICMJE | November 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00025285 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer | ||||||||
| Official Title ICMJE | Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer | ||||||||
| Brief Summary | RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells and be an effective treatment for stage IIIB or stage IV non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease receive up to 6 courses of therapy. Patients also receive oral thalidomide once daily beginning on day 1 and continuing until disease progression. Patients are followed every 3 months until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 39-70 patients will be accrued for this study within 14 months. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE | Lung Cancer | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00025285 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000068946, CCCWFU-62400, NCI-5293 | ||||||||
| Study Sponsor ICMJE | Wake Forest University Baptist Medical Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University Baptist Medical Center | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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