Status:
COMPLETED
Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
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. Se...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00114192
Start Date
June 1 2004
Last Update
February 1 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908