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An Open Label Study of the Safety of First-Line Treatment With Avastin in Combination With Cisplatin-Gemcitabine or Carboplatin-Paclitaxel in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

An Open Label Study of the Safety of First-Line Treatment With Avastin in Combination With Cisplatin-Gemcitabine or Carboplatin-Paclitaxel in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage


Inclusion Criteria:



- adult patients, >=18 years of age;

- documented squamous non-small cell lung cancer;

- stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;

- suitable for platinum-based treatment as first line chemotherapy.

Exclusion Criteria:

- prior systemic anti-tumor therapy;

- prior radiotherapy for treatment of patient's current stage of disease;

- other primary tumors within last 5 years, except for controlled limited basal cell or
squamous cancer of the skin, or cancer in situ of the cervix;

- major surgery, open biopsy or significant traumatic injury within 28 days prior to
randomization.

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:

Rate of grade >=3 Avastin-related pulmonary hemorrhage

Outcome Time Frame:

After a maximum of 12 months treatment

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

BO19734

NCT ID:

NCT00404703

Start Date:

Completion Date:

March 2008

Related Keywords:

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

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