3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.

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

Details

• Lead Sponsor: Cancer Therapeutics Research Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

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

• Stage III or IV disease

• One of the following cellular types:

• Adenocarcinoma

• Non-diffuse bronchoalveolar cell carcinoma

• Large cell carcinoma

• Squamous cell carcinoma NOTE: *A repeat biopsy of any accessible tumor site is required if > 5 years have elapsed since the initial diagnosis

• Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage III or IV NSCLC and must have achieved, at least once, a partial response, complete response, or stable disease during therapy

• Not a primary non-responder and experienced only progressive disease during gemcitabine-containing chemotherapy

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• No glucose-6-phosphate dehydrogenase (G6PD) deficiency

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 1.5 times ULN OR

• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No prior uncontrolled cardiac disease

• No myocardial infarction within the past 12 months

• No symptomatic congestive heart failure

• No coronary artery disease

• No cardiac arrhythmia

Pulmonary

• No uncontrolled symptomatic pulmonary disease

• No pulmonary disease that requires oxygen therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except completely treated carcinoma in situ of the cervix or nonmelanoma skin cancer

• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents

• No other concurrent uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies