RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with pyrazoloacridine in treating patients with stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: I. Evaluate the antitumor activity of pyrazoloacridine (PZA) administered by 3-hour infusion to patients with advanced non small cell lung cancer (NSCLC). II. Determine the qualitative and quantitative toxicities of PZA administered on this schedule. III. Determine the response and survival durations of NSCLC patients treated with PZA. OUTLINE: Single-Agent Chemotherapy. Pyrazoloacridine, PZA, NSC-366140. PROJECTED ACCRUAL: If 2 or 3 responses are observed in the first 18 evaluable patients, 12 additional patients will be entered. Accrual is expected to take 5-12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity. Depending on the prior cycle toxicity the dose should be escalated, maintained or reduced, utilizing levels: -1, 0 (initial dose level), 1 - Level +1 (820mg/m2); Level 0 (750mg/m2); Level -1 (600mg/m2)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Evaluate toxicity of pyrazoloacridine.
Time frame: Weekly prior to each treatment cycle.
Evaluate the response frequency of pyrazoloacridine.
Time frame: After 2 treatment cycles then every 2 months
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