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