Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

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Lung

Brief Title

Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

Official Title

A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer

Brief Summary

      This phase I trial studies 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. 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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest
      radiotherapy in patients with locally advanced non-small cell lung cancer.

      II. Characterize the toxicity of this treatment regimen. III. Assess the clinical response to
      this treatment regimen. IV. 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and feasibility


Condition

Adenocarcinoma of the Lung

Intervention

3-dimensional conformal radiation therapy

Study Arms / Comparison Groups

 Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

36

Start Date

June 2006


Primary Completion Date

February 2008

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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 normalOR 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

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Everett Vokes, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00369551

Organization ID

NCI-2012-02718

Secondary IDs

NCI-2012-02718

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Everett Vokes, Principal Investigator, University of Chicago


Verification Date

January 2013