Status:
COMPLETED
Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
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, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen is more effectiv...
Detailed Description
OBJECTIVES: Primary * Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unrese...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Unresectable stage IIIB or IV disease
- No untreated brain or leptomeningeal metastases
- Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment
- No symptomatic (i.e., requiring thoracentesis) pleural effusion
- No clinically significant (i.e., grade 3 or greater) pericardial effusion
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2 (70 years of age and over) OR
- ECOG 2 (under 70 years of age)
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 8.0 g/dL
- Hepatic
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR
- Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No grade 2 or greater peripheral neuropathy
- No prior hypersensitivity reaction to taxanes or products containing polysorbate 80
- No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less)
- No concurrent radiotherapy
- Surgery
- More than 3 weeks since prior major surgery
- Other
- More than 30 days since prior anticancer investigational drugs
- Concurrent supportive care investigational agents allowed
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00075374
Start Date
October 1 2003
End Date
April 1 2005
Last Update
January 16 2014
Active Locations (1)
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1
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065