Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III 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, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Treatments: Carboplatin; Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:

• Stage IIIB disease* that is not suitable for radical radiotherapy

• Stage IV disease* NOTE: *Radiographically verified

• At least 1 measurable lesion by clinical examination or radiography

• No mixed histologies of small cell lung cancer and NSCLC

• No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• WBC ≥ 3,000/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

Hepatic

• AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Alkaline phosphatase < 3 times ULN

• Bilirubin < 1.5 times ULN

Renal

• Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA clearance)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able and willing to participate in the quality of life assessment

• No pre-existing neuropathy > grade 2

• No other malignancy that would preclude study treatment or study comparisons

• No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation

• No psychiatric disorder that would preclude study participation

• No other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy

• No other concurrent cytotoxic chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except contraceptives or replacement steroids

Radiotherapy

• No prior radiotherapy

Surgery

• Recovered from prior surgery

• Prior surgical resection for NSCLC allowed

Other

• More than 12 weeks since prior investigational agents and recovered

• No other concurrent specific antitumor therapy

• No other concurrent investigational agents