3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

OBJECTIVES:

• Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine.
• Determine the progression-free and overall survival in patients treated with this regimen.
• Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Metastatic disease
• Progressive disease after no more than 2 prior cytotoxic regimens containing at least 1 of the following drugs:

• Cisplatin
• Carboplatin
• Taxane
• Vinorelbine
• Measurable disease
• No CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• Chronic viral hepatitis allowed

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months
• No uncontrolled congestive heart failure
• No uncontrolled coronary artery disease
• No uncontrolled cardiac arrhythmias

Pulmonary

• No dyspnea at rest
• No supplemental oxygen dependence

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No active infection
• No other prior or concurrent malignancy except carcinoma in situ of the cervix previously treated by cone biopsy and/or resection, nonmetastatic basal cell or squamous cell skin cancer, or any stage I malignancy curatively resected more than 5 years ago
• No other concurrent life-threatening illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior non-cytotoxic biologic regimens allowed (e.g., vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors)

Chemotherapy

• See Disease Characteristics
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior gemcitabine
• No prior 3-AP

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• More than 3 weeks since prior surgery and recovered

Other

• More than 3 weeks since prior non-cytotoxic regimens