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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00334763
Recruitment Status : Terminated (Principal Investigator felt risk to patients was too high.)
First Posted : June 8, 2006
Last Update Posted : July 10, 2012
National Cancer Institute (NCI)
Information provided by:
Northwestern University

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: bevacizumab Drug: carboplatin Drug: chemoprotection Drug: paclitaxel Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. Reduction in toxicity measured by pulmonary hemorrhage rate

Secondary Outcome Measures :
  1. Overall survival by Kaplan-Meier
  2. Response rate
  3. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00334763

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United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Principal Investigator: Jyoti D. Patel Robert H. Lurie Cancer Center

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Responsible Party: Jyoti D. Patel, Robert H. Lurie Comprehensive Cancer Center at Northwestern University Identifier: NCT00334763     History of Changes
Other Study ID Numbers: NU 05L1
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Northwestern University:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors