Lung Cancer
Conditions
Keywords
stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel, carboplatin, and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell lung cancer. * Determine, preliminarily, the response rate and survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of tirapazamine. Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Beginning on day 1, patients undergo radiotherapy once daily 5 days a week for 6.5 weeks. Beginning 4-5 weeks after completion of radiotherapy, patients with stable or responding disease receive consolidation chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22. Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Interventions
Sponsors
National Cancer Institute (NCI)
California Cancer Consortium
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary bronchogenic non-small cell lung cancer * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Stage IIIA or IIIB disease (T1-4, N2-3) * Mediastinal lymph nodes at least 2 cm in diameter by radiography sufficient to stage N2-3 (must be node positive \[cytologically or histologically confirmed\] if largest mediastinal node is less than 2 cm in diameter) OR * Selected stage IIB disease (T3, N0 or T3, N1 with a medical condition that precludes surgery) * No malignant pleural effusion * Measurable or evaluable disease by chest x-ray or CT scan * No metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count normal Hepatic: * Not specified Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled congestive heart failure * No unstable angina * No unstable cardiac arrhythmias Pulmonary: * FEV\_1 at least 1.0 L Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant hearing loss PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for lung cancer Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for lung cancer Surgery: * See Disease Characteristics
Countries
United States
Outcome results
None listed