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Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00369551
  Purpose

RATIONALE: 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. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • In-field toxicity, defined as bleeding or perforation of the tracheobronchial or gastrointestinal structures within the radiation field [ Designated as safety issue: Yes ]
  • Clinical response [ Designated as safety issue: No ]
  • Correlation of levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2005
Detailed Description:

OBJECTIVES:

  • Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest radiotherapy in patients with locally advanced non-small cell lung cancer.
  • Characterize the toxicity of this treatment regimen.
  • Assess the clinical response to this treatment regimen.
  • Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen.

OUTLINE: This is an open-label, multicenter study.

  • Induction therapy: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
  • Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After study completion, patients are followed periodically for 36 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:

    • The following subtypes are eligible:

      • Adenocarcinoma (including bronchoalveolar)
      • Large cell carcinoma (including giant and clear cell carcinomas)
      • Poorly differentiated carcinoma
    • No squamous cell histology
    • Unresectable stage II-III disease
    • Tumor must not invade the trachea or major arterial or venous structures
  • Measurable or evaluable disease

    • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
  • No evidence of CNS disease, including primary brain tumor or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
  • Life expectancy > 6 months
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin < 1.25 times upper limit of normal (ULN)
  • AST < 2.5 times ULN
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • FEV_1 ≥ 1.0 liters
  • 24-hour urine protein < 1,000 mg (for patients with urine protein:creatinine ratio [by urine analysis] > 1.0)
  • No hemoptysis within the past 12 months (defined as bright red blood in sputum of > 1 teaspoon)
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of allergic reactions attributed to carboplatin or taxane
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 14 days
  • No clinically significant cardiovascular disease, including any of the following:

    • Cerebrovascular accident within the past 6 months
    • Uncontrolled hypertension
    • Myocardial infarction or unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Unstable angina pectoris
    • Clinically significant peripheral vascular disease
  • No known bleeding diathesis or coagulopathy
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No uncontrolled intercurrent illness including, but not limited to, the following:

    • Ongoing or active infection
    • Psychiatric illness or social situations that would limit study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior epidermal growth factor receptor-targeted therapy
  • No prior vascular endothelial growth factor-targeted therapy
  • No prior chest radiotherapy
  • No major surgery or open biopsy within the past 14 days
  • No concurrent treatment with full-dose anticoagulation

    • Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:

      • Daily dose of warfarin < 1 mg
      • INR < 1.5
  • No other concurrent investigational agents
  • No concurrent major surgical procedures
  • No other concurrent anticancer agents or therapies
  • No concurrent chronic treatment with aspirin (> 325 mg daily) or nonsteroidal anti-inflammatory agents
  • No dexamethasone as an antiemetic during chemoradiotherapy
  • No colony-stimulating factors during chemoradiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369551

Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Everett E. Vokes, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000491998, UCCRC-14576A, NCI-7213
Study First Received: August 24, 2006
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00369551  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer
stage II non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Carboplatin
Bevacizumab
Carcinoma
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009