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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,500/mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count > 100,000/mm^3 Hepatic 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 Renal Creatinine < 1.5 mg/dL Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy 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 Radiotherapy Recovered from prior radiotherapy Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete and partial response rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Response duration |  |  | 
| Survival |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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