Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori
• Treatments: Docetaxel

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