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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer.

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

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Gemcitabine

Criteria

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