Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00334763 | Terminated Phase 2

• 4 other identifiers: NU 05L1NU-05L1NU-1362-038GENENTECH-AVF3646s
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. 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 radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Reduction in toxicity measured by pulmonary hemorrhage rate

Secondary Outcomes (3)

• Overall survival by Kaplan-Meier

• Response rate

• Toxicity

Interventions

bevacizumab BIOLOGICAL

carboplatin DRUG

chemoprotection DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Predominantly squamous cell histology * Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy * Advanced disease, meeting 1 of the following staging criteria: * Stage IIIB disease with malignant pleural effusion * Stage IV disease * Recurrent, unresectable disease * Measurable or nonmeasurable disease * No extrathoracic only disease * No known CNS metastases by head CT scan with contrast or MRI PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Bilirubin \< 1.5 mg/dL * Transaminases \< 5 times upper limit of normal (ULN) * Creatinine clearance ≥ 45 mL/min * Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis * INR \< 1.5 ULN * PTT normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients use effective contraception * No serious nonhealing wound, ulcer, or bone fracture * No ongoing or active infection * No ongoing fever * No myocardial infarction within the past 6 months * No stroke within the past 6 months * No history of hypertension unless well-controlled (i.e., blood pressure \< 150/100 mmHg on a stable regimen of antihypertensive therapy) * No New York Heart Association grade III or IV congestive heart failure * No serious cardiac arrhythmia requiring medication * No unstable angina pectoris * No peripheral vascular disease ≥ grade 2 * No other clinically significant cardiovascular disease * No abdominal fistula * No gastrointestinal perforation * No intra-abdominal abscess within the past 6 months * No psychiatric illness or social situation that would preclude study compliance * No other malignancy curatively treated within the past 5 years * No history of thrombotic or hemorrhagic disorders * No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months * No bleeding requiring intervention or ≥ grade 2 PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * No prior systemic chemotherapy for metastatic NSCLC * More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage IB-IIIA) NSCLC * More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy * More than 28 days since prior and no concurrent major surgery * More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy * More than 4 weeks since prior and no concurrent participation in another experimental drug study * No concurrent therapeutic anticoagulation * Concurrent prophylactic anticoagulation of venous access device allowed * No concurrent chronic treatment with aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function * No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Jyoti D. Patel

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

US (5)