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

June 9, 2010 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Michigan
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
- Ohio
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease response Time Frame: every 12 weeks	every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 27, 2003

First Submitted That Met QC Criteria