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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: cisplatin; Drug: docetaxel

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00005868

EORTC-08984

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.
• Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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