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

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Stage II Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

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Trial Information

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


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and feasibility

Outcome Time Frame:

Up to 36 months

Safety Issue:


Principal Investigator

Everett Vokes

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Stage II Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470