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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00053300
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
2
Locations
92
Duration (Months)
15
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Aug 1, 2002
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Apr 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Disease response [every 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
2 Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106-5065

Sponsors and Collaborators

  • Case Comprehensive Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Afshin Dowlati, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00053300
Other Study ID Numbers:
  • CWRU1502
  • P30CA043703
  • CASE-CWRU-1502
  • CELGENE-CWRU-1502
  • CASE-1502
First Posted:
Jan 28, 2003
Last Update Posted:
Jun 10, 2010
Last Verified:
Jun 1, 2010
Keywords provided by , ,
extensive stage small cell lung cancer
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Thalidomide

Study Results

No Results Posted as of Jun 10, 2010