A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Phase 2
Terminated
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Drug: Platinum-based chemotherapy
- Registration Number
- NCT00404703
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 Platinum-based chemotherapy -
- Primary Outcome Measures
Name Time Method Rate of grade >=3 Avastin-related pulmonary hemorrhage After a maximum of 12 months treatment
- Secondary Outcome Measures
Name Time Method Overall response, duration of response, progression-free survival. Event driven AEs, laboratory parameters, coagulation parameters. Throughout study