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Phase II Study of Thalidomide in Patients With Extensive-Stage Small Cell Lung Cancer Who Achieve a Complete or Partial Response to Induction Chemotherapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry CASE-CWRU-1502
CELGENE-CWRU-1502, NCT00053300, CASE-1502

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.

Entry Criteria

Disease Characteristics:

Diagnosis of extensive-stage small cell lung cancer

Complete or partial response after 4-6 courses of induction chemotherapy

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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

Expected Enrollment

A total of 30 patients will be accrued for this study within approximately 18 months.

Outcomes

Primary Outcome(s)

Disease repsonse every 12 weeks
Time to progression every 12 weeks
Survival every 3 months

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.

Published Results

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.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Afshin Dowlati, MD, Protocol chair
Ph: 216-844-1228

Registry Information

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

Trial Start Date		2002-08-30

Registered in ClinicalTrials.gov		NCT00053300

Date Submitted to PDQ		2002-11-20

Information Last Verified		2006-02-23

NCI Grant/Contract Number		P30-CA43703

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.