Overview

Combination Chemotherapy in Treating Patients With 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 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 combining cisplatin with gemcitabine in treating patients who have 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:
Cisplatin
Gemcitabine
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer Locally advanced Stage IIIB (T4, Nx, M0, or Tx, N3, M0) OR Metastatic disease Stage
IV unresectable disease Following cell types eligible: Epidermoid cell Large cell
Adenocarcinoma Bidimensionally measurable disease Unresectable recurrence after primary
surgery allowed No brain metastasis

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: AST and ALT no greater than 3
times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine
no greater than 1.10 mg/dL Cardiovascular: No uncontrolled cardiac disease Other: No other
significant, uncontrolled underlying medical or psychiatric condition No serious active
infection Neurologically stable No other prior malignancy except treated nonmelanomatous
skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics Other: At least 30 days since prior experimental therapy No
other concurrent experimental drugs