3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer
Eligibility 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
Sites / Locations
- Sydney Cancer Centre at Royal Prince Alfred Hospital
- Sir Charles Gairdner Hospital - Perth
- Prince of Wales Hospital
- Yonsei Cancer Center at Yonsei University Medical Center
- Cancer Institute at National University Hospital
- National University of Singapore
- National Cancer Centre - Singapore
- Johns Hopkins Singapore International Medical Centre