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

NCT ID: NCT00334763

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-11-30

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.

Detailed Description

OBJECTIVES:

Primary

• Evaluate reduction in toxicity, in terms of pulmonary hemorrhage, in patients with recurrent, unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel, carboplatin, and bevacizumab.

Secondary

• Determine the overall and progression-free survival of patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy to the primary tumor, clinically involved lymph nodes, and any other disease-causing symptoms or bronchial compression once daily, 5 days a week, for 2 weeks in weeks 1 and 2. Beginning in week 4, patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel, carboplatin, and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity. Patients achieving complete response, partial response, or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

chemoprotection

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Principal Investigators

Jyoti D. Patel

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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

Dallas, Texas, United States

Countries

United States

Other Identifiers

NU-05L1

Identifier Type: -

Identifier Source: secondary_id

NU-1362-038

Identifier Type: -

Identifier Source: secondary_id

GENENTECH-AVF3646s

Identifier Type: -

Identifier Source: secondary_id

NU 05L1

Identifier Type: -

Identifier Source: org_study_id