Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center; Nathan Pennell, MD, PhD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Erlotinib Hydrochloride; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Surgically determined stage IIIA or IIIB disease

• Histology from an involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs

• Histological or cytological proof of mediastinal nodal involvement by mediastinoscopy, Chamberlain procedure, thoracoscopy, thoracotomy, or CT-guided biopsy is required except for cases of paralysis of left true vocal cord with separate left lung primary distinct from enlarged nodes > 1 cm in the anterior-posterior window seen on the CT scan

• Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy

• Measurable and evaluable disease

• No malignant pleural effusion except for effusion visible only on CT scan and deemed too small to tap

• No pericardial effusion

• No small or mixed small cell/non-small cell lung cancer

• No massive lesions requiring radiation to the entire lung

• No metastatic cancer to the lungs

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC ≥ 3,000/mm^3

• Platelet count > 100,000/mm^3

• Serum creatinine ≤ 2.0 mg/dL

• Alkaline phosphatase, AST, and ALT < 2 times upper limit of normal

• Albumin > 3.0 g/dL

• Serum bilirubin < 1.5 mg/dL

• Adequate pulmonary function

• No clinical evidence of another uncontrolled malignancy

• No requirement for urgent therapy for severe local symptoms such as post-obstructive pneumonia

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, radiation therapy, or immunotherapy for lung cancer

• No prior surgery to treat the cancer