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Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114192
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : February 1, 2010
National Cancer Institute (NCI)
Information provided by:
University of Virginia

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: thalidomide Phase 2

Detailed Description:



  • Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.


  • Determine the toxicity of this regimen in these patients.
  • Determine the response duration and survival of patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses of treatment may continue study treatment at the discretion of the investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with thalidomide at the discretion of the investigator.

Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and then every 3 months thereafter.

After completion of study treatment, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
Study Start Date : June 2004
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Complete and partial response rates

Secondary Outcome Measures :
  1. Toxicity
  2. Response duration
  3. Survival
  4. Quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:

    • Stage IIIB (with pleural effusion)
    • Stage IIIA or IIIB

      • Previously treated and not eligible for surgery or definitive thoracic radiotherapy
    • Stage IV
  • Measurable or evaluable disease
  • Documented disease progression during or after standard first-line chemotherapy that may have included taxane
  • No untreated brain metastases

    • Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count > 100,000/mm^3


  • Bilirubin normal
  • SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
  • SGOT and/or SGPT normal AND alkaline phosphatase ≤ 4 times ULN AND no ascites
  • Albumin > 3.0 g/dL


  • Creatinine < 1.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception for 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  • No HIV positivity
  • No peripheral neuropathy > grade 1
  • No other malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
  • No active infections
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease

    • Prior neoadjuvant or adjuvant systemic chemotherapy allowed
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified


  • Recovered from prior radiotherapy


  • Not specified


  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114192

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United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
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Principal Investigator: Heidi Gillenwater, MD University of Virginia

Layout table for additonal information Identifier: NCT00114192    
Other Study ID Numbers: 11212
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: January 2010
Keywords provided by University of Virginia:
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors