Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00053300
Last Updated: 2010-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2002-08-31
2010-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.
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Detailed Description
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* Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within approximately 18 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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thalidomide
oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
adjuvant therapy
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of extensive-stage small cell lung cancer
* Complete or partial response after 4-6 courses of induction chemotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 2 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study
* No greater than grade 1 peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigators
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Afshin Dowlati, MD
Role: STUDY_CHAIR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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References
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Cooney MM, Subbiah S, Chapman R, et al.: Phase II trial of maintenance daily oral thalidomide in patients with extensive-stage small cell lung cancer (ES-SCLC) in remission. [Abstract] J Clin Oncol 23 (Suppl 16): A-7166, 661s, 2005.
Other Identifiers
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CASE-CWRU-1502
Identifier Type: OTHER
Identifier Source: secondary_id
CELGENE-CWRU-1502
Identifier Type: -
Identifier Source: secondary_id
CASE-1502
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU1502
Identifier Type: -
Identifier Source: org_study_id
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