This trial is active, not recruiting.

Condition lung cancer
Treatments docetaxel, quality-of-life assessment
Phase phase 3
Sponsor Istituto Nazionale per lo Studio e la Cura dei Tumori
Start date December 2000
Trial size 200 participants
Trial identifier NCT00022022, CDR0000068702, EU-20103, ITA-INTN-DISTAL


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Quality of life
time frame:
time frame:
Response rate
time frame:
Time to progression
time frame:
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).