Trial information
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer.
Status: Terminated
Protocol number: BO19734
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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. Target sample size is
70.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Rate of grade >=3 Avastin-related pulmonary hemorrhage Time frame: After a maximum of 12 months treatment
Key secondary outcomes: 1. Overall response, duration of response, progression-free survival. Time frame: Event driven
2. AEs, laboratory parameters, coagulation parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Czech Republic
France
Hungary
- Szekesfehervar
- Szombathely
Israel
Poland
- Lublin
- Poznan
- Szczecin
- Warszawa
Russian Federation
- Balashikha
- Moscow
- St. Petersburg
Spain
Taiwan
- Kueishan
- Taichung
- Taipei
- Taoyuan
