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An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) 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

An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.


Inclusion Criteria:



- adult patients, >= 18 years of age;

- non-squamous non-small cell lung cancer, locally advanced and unresectable;

- ECOG performance status 0 or 1;

- no prior thoracic or head and neck radiation;

- no prior surgical resection for current lung cancer.

Exclusion Criteria:

- malignancies other than non-small cell lung cancer within 2 years prior to inclusion,
except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in
situ of the cervix;

- prior systemic therapy for non-small cell lung cancer;

- clinically significant cardiovascular disease;

- history of >= grade 2 hemoptysis;

- current or recent use of aspirin (>325mg/day) or full dose anticoagulants or
thrombolytic agents for therapeutic purposes.

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:

Dose limiting toxicity

Outcome Time Frame:

Throughout Study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

BO21563

NCT ID:

NCT00776698

Start Date:

April 2009

Completion Date:

February 2010

Related Keywords:

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

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