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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Afshin Dowlati, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000346070
NCT ID:
NCT00075374
Start Date:
October 2003
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- recurrent non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
