A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer
docetaxel
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location