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TerminatedNCT00334763Updated Jul 10, 2012

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

A Phase 2 interventional study of bevacizumab and carboplatin in Lung Cancer, sponsored by Northwestern University. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-10.

Sponsored by Northwestern University · Phase 2, Interventional, and Treatment

Why this study was terminated
Principal Investigator felt risk to patients was too high.
Phase
Phase 2
Study type
Interventional
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 32 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
32 participants (estimated)

Interventions

  • Biologicalbevacizumab
  • Drugcarboplatin
  • Drugchemoprotection
  • Drugpaclitaxel
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Reduction in toxicity measured by pulmonary hemorrhage rate

Secondary outcomes

  1. Overall survival by Kaplan-Meier

  2. Response rate

  3. Toxicity

07

Study locations

5 sites
  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    Birmingham, Alabama 35294, United States
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Evanston Northwestern Healthcare - Evanston Hospital
    Evanston, Illinois 60201-1781, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00334763
Lead sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
First posted
Jun 8, 2006
Start date
May 2006
Primary completion
May 2007
Completion
Nov 2007
Last update
Jul 10, 2012

Study contacts

Jyoti D. Patel
principal investigator · Robert H. Lurie Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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