Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II 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 cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy before surgery is more effective than giving it after surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and cisplatin to compare how well they work when given before or after surgery in treating patients with stage I or stage II non-small cell lung cancer.

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

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Squamous cell or nonsquamous cell histology

• Stage IB or II disease

• Tumor amenable to curative surgical resection

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Not pregnant or nursing

• Negative pregnancy test

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

• Medical fitness must be adequate for radical NSCLC surgery

• WBC ≥ 4,000/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Bilirubin normal

• ALT and AST ≤ 2.5 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL

• No second primary malignancy

• No active uncontrolled infection

• No concurrent serious disorder that would compromise patient safety or tolerance of study therapy

• No significant neurological or mental disorder

• No myocardial infarction within the past 6 months

• No symptomatic heart disease, including any of the following:

• Unstable angina

• Congestive heart failure

• Uncontrolled arrhythmia

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or anticancer therapy

• No prior surgery for NSCLC

• No prior or concurrent radiotherapy or immunotherapy (e.g., biologic response modifier)

• No major surgery (other than biopsy) within the past 2 weeks

• No other concurrent anticancer therapy

• No other concurrent investigational agents