Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Tirapazamine

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