Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV 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, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.

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

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Docetaxel; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:

• Epidermoid carcinoma

• Large cell carcinoma

• Adenocarcinoma

• Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease

• Inoperable disease

• Measurable disease

• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

• Absolute neutrophil count at least 2,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than normal

• Transaminases no greater than 1.5 times normal

• Alkaline phosphatase no greater than 2.5 times normal

Renal

• Creatinine no greater than 2.3 mg/dL

Cardiovascular

• No uncontrolled cardiac insufficiency

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 6 months after study therapy

• No uncontrolled infection

• No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

• No grade 3 or 4 brain disorder

• No intolerance to polysorbate 80 or cortisones

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy, including taxanes or gemcitabine

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to more than 20% of the bone marrow

• No prior radiotherapy for lung cancer

• At least 4 weeks since other prior radiotherapy and recovered

Surgery

• No prior surgery for lung cancer

Other

• More than 30 days since prior clinical trial participation