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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 27, 2003

Last Updated Date

February 6, 2009

Start Date ^†

August 2002

Current Primary Outcome Measures ^†

Disease repsonse every 12 weeks [ Designated as safety issue: No ]
Time to progression every 12 weeks [ Designated as safety issue: No ]
Survival every 3 months [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00053300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

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.

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Lung Cancer

Intervention ^†

Drug: thalidomide
Procedure: adjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00053300

Responsible Party

Secondary IDs ^††

CASE-CWRU-1502, CELGENE-CWRU-1502, CASE-1502

Study Sponsor ^†

Case Comprehensive Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Afshin Dowlati, MD

Case Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.