Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer

• Status: Completed
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cisplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)

• Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes

• Measurable disease

• Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan

• No distant metastases

• No CNS involvement

• No pleural or pericardial effusion

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• AST/ALT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.25 ULN

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No superior vena cava syndrome

• No uncontrolled congestive heart failure or angina

• No myocardial infarction within past year

• No uncontrolled hypertension or arrhythmia

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No concurrent active infection requiring IV antibiotic therapy

• No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma

• No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)

• No motor or sensory neurotoxicity of grade 2 or greater

• No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy for NSCLC

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• No prior radiotherapy for NSCLC

• No concurrent radiotherapy

Surgery:

• No prior surgery for NSCLC

Other:

• At least 1 month since prior investigational agents

• No other concurrent experimental medications