Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Carboplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

• No squamous cell carcinoma

• No histology in close proximity to a major vessel

• Resectable stage IB-IIIA disease

• No CNS or brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 8.0 g/dL

• Bilirubin normal

• Creatinine ≤ 1.5 mg/dL

• Urine protein:creatinine < 1.0

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

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

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

• AP ≤ 5 times ULN AND AST and ALT normal

• Not pregnant or nursing

• Negative pregnancy test

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

• Adequate pulmonary and cardiovascular function to tolerate surgical resection

• No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon)

• No existing peripheral neuropathy ≥ grade 1

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

• No history of serious systemic disease, including any of the following:

• Myocardial infarction within the past 6 months

• Uncontrolled hypertension (i.e., blood pressure > 150/110 mm Hg on medication)

• Unstable angina

• New York Heart Association class II-IV congestive heart failure

• Unstable symptomatic arrhythmia requiring medication

• Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible

• Clinically significant peripheral vascular disease (i.e., grade II or higher)

• No history of significant neurological or psychiatric condition

• No known active infection within the past 14 days

• No serious, nonhealing wound, ulcer, or bone fracture

• No evidence of bleeding diathesis or coagulopathy

• No stroke within the past 6 months

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

• No other serious illness or medical condition

• No active infection

• No other currently active malignancy except nonmelanoma skin cancer

• Malignancies for which therapy has been completed and are considered to have ≤ 30% chance of risk of relapse are not considered active

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or VEGF inhibitor

• No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in another experimental drug study except a Genentech-sponsored bevacizumab cancer study

• No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days

• No anticipation for major surgical procedure during study treatment

• No fine-needle aspiration or core biopsy within 7 days prior to study entry

• No concurrent full-dose anticoagulation

• No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy for this cancer