Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Eli Lilly and Company; Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer

• Stage IIIA or IIIB disease

• No malignant pleural or pericardial effusions

• No palpable supraclavicular adenopathy

• Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)

• Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Hemoglobin ≥ 9.0 mg/dL

• Platelet count ≥ 100,000/mm³

• Absolute neutrophil count (ANC) ≥ 1,500/mm³

• Forced expiratory volume 1 (FEV_1) ≥ 1 L

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times ULN

• Bilirubin normal

• Partial thromboplastin time (PTT) and international normalized ratio (INR) normal

• Urine protein:creatinine ratio < 1.0

• Blood pressure ≤ 150/100 mm Hg on 3 separate occasions

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No significant recent hemoptysis (> ½ teaspoon of bright red blood)

• No unstable angina

• No New York Heart Association (NYHA) congestive heart failure ≥ class II

• No myocardial infarction or stroke within the past 6 months

• No clinically significant peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No serious, non-healing wound, ulcer, or bone fracture

• No thrombosis requiring therapeutic anticoagulation

• No significant traumatic injury within the last 28 days

PRIOR CONCURRENT THERAPY:

• Recovered from prior surgery

• At least 4 weeks since prior and no concurrent participation in another experimental drug study

• At least 4 weeks since prior and no concurrent major surgical procedure or open biopsy

• At least 2 weeks since prior mediastinoscopy or mediastinotomy

• At least 1 week since prior fine needle aspirations or core biopsies

• No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

• No other concurrent investigational agents