Overview

Gemcitabine Plus Carboplatin or Cisplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

Status:
Completed

Trial end date:
2004-08-01

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: Randomized phase II trial to compare the effectiveness of gemcitabine plus carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Herbert Irving Comprehensive Cancer Center

Treatments:

Carboplatin
Cisplatin
Gemcitabine

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV
non-small cell lung cancer (NSCLC) Recurrent NSCLC treated with radiation or surgery
allowed Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam outside
of irradiation field No active CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count
greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL
Hematocrit at least 30% Hepatic: Bilirubin no greater than 2 mg/dL PT or aPTT no greater
than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (5 times
ULN if liver metastases present) Renal: Creatinine no greater than 2 mg/dL Other: Not
pregnant or nursing Fertile patients must use effective contraception during and for 3
months after study No serious concurrent systemic disorder that would preclude study
compliance No active infection No second primary malignancy within the past 5 years,
except: Adequately treated basal cell skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent
chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No
concurrent hormonal therapy (except contraceptives and replacement steroids) Radiotherapy:
See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent
radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior
investigational drugs No other concurrent experimental drugs No concurrent interleukin-11
for patients with cardiac disease