Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
18 Years
75 Years
Both
Lung Cancer
Trial Information
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
OBJECTIVES:
- Compare the quality of life of patients with stage IIIB or IV non-small cell lung
cancer treated with 2 different schedules of docetaxel as second-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the response rate, time to progression, and survival of these patients treated
with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or
complete response vs stable disease vs progressive disease), and prior cisplatin-containing
chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a
maximum of 6 courses.
- Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8
weeks for a maximum of 2 courses.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and
days 22 and 43 for arm II.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer
(NSCLC)
- Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
- Progressive disease
- Must have received prior chemotherapy
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no
greater than 1.25 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
Cardiovascular:
- No prior or concurrent cardiovascular disease that would preclude study
Pulmonary:
- See Disease Characteristics
- No prior or concurrent pulmonary disease that would preclude study
Other:
- No prior or other concurrent illness or medical condition that would preclude study
- No other prior malignancy except adequately treated carcinoma in situ of the cervix
or nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior docetaxel
- At least 3 weeks since other prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy allowed
- No concurrent radiotherapy
Surgery:
- Prior radical surgery for NSCLC allowed
- Concurrent palliative surgery allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Quality of life
Safety Issue:
No
Principal Investigator
Cesare Gridelli, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Istituto Nazionale per lo Studio e la Cura dei Tumori
Authority:
United States: Federal Government
Study ID:
CDR0000068702
NCT ID:
NCT00022022
Start Date:
December 2000
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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