NCT00053300

Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase II Trial of Daily Thalidomide in Extensive Stage Small Cell Lung Cancer Patients Achieving a Complete or Partial Response to Induction Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-08-01
• Primary completion: 2005-11-01
• Completion: 2010-04-01
• First posted: 2003-01-28
• Last updated: 2010-06-10

Locations

2 sites across 1 country: United States