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Status:

TERMINATED

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

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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, eith...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2007

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00334763

    Start Date

    May 1 2006

    End Date

    November 1 2007

    Last Update

    July 10 2012

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    3

    Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, United States, 60201-1781

    4

    Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, United States, 37232-6838

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