Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
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.
OBJECTIVES:
Primary
Secondary
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.
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
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
Radiotherapy
Surgery
Other