Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00053300|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : June 10, 2010
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: thalidomide Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Daily Thalidomide in Extensive Stage Small Cell Lung Cancer Patients Achieving a Complete or Partial Response to Induction Chemotherapy|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||April 2010|
- Drug: 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
- Procedure: 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.
- Disease response [ Time Frame: every 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053300
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Afshin Dowlati, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|