Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together with radiation therapy followed by docetaxel works in treating patients with newly diagnosed stage III non-small cell lung cancer.

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

Details

• Lead Sponsor: University of Miami
• Treatments: Camptothecin; Carboplatin; Docetaxel; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

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

• Stage IIIA or IIIB disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan

• No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Absolute neutrophil count > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL

• Bilirubin normal

• Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

• AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)

• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

• AP ≤ 5 times ULN AND AST or ALT normal

• Creatinine < 2.0 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

• No New York Heart Association class III-IV heart disease

• No history of serious cardiac disease not adequately controlled

• No documented myocardial infarction within the past 6 months

• No congestive heart failure

• No unstable angina

• No clinically significant arrhythmia

• No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80

• No peripheral neuropathy > grade 1

• No other malignancy within the past 5 years other than skin cancer

PRIOR CONCURRENT THERAPY:

• More than 3 weeks since prior major surgery

• No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC