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A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer


Inclusion Criteria:



- patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;

- ECOG performance status of 0 or 1;

- no prior thoracic head and neck irradiation or surgical resection for current lung
cancer.

Exclusion Criteria:

- mixed, non-small cell and small cell tumors;

- mixed adeno-squamous carcinomas with a predominant squamous component;

- evidence of tumor invasion or encasement of major vessels;

- history of grade >=2 hemoptysis;

- presence of cavitations in lung lesions at baseline.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

BO21247

NCT ID:

NCT00773188

Start Date:

December 2008

Completion Date:

October 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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