Lung Cancer Clinical Trial
Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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 effective for non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer.
Full 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 unresectable stage IIIB or IV non-small cell lung cancer.
Secondary
Compare the overall survival of patients treated with these regimens.
Compare the response rate in patients treated with these regimens.
Compare the incidence of serious adverse events in patients treated with these regimens.
Determine the quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion.
Patients are followed at 1 month and then every 2-3 months thereafter.
PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) will be accrued for this study.
Eligibility Criteria
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
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There is 1 Location for this study
Cleveland Ohio, 44106, United States
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