Trial information
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-Small Cell Lung Cancer.
Status: Recruiting
Protocol number: ML20081
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the effect of first-line treatment with Avastin in combination with docetaxel and cisplatin on progression-free survival in patients with metastatic or locally advanced non-small cell lung cancer.
Brief summary: This study will assess the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients will receive Avastin 15mg/kg i.v., docetaxel 75mg/kg and cisplatin 75mg/m2 on day 1 of each 3 week cycle, for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 47.
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. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Duration of survival; response rate Time frame: Event driven
2. AEs, lab parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- stage IIIb or IV non-small cell lung cancer;
- chemotherapy-naive.
Exclusion criteria:
- previous treatment for non-small cell lung cancer;
- previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of study;
- recent or current chronic treatment with aspirin (>325mg/day).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 04/17/2008
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alcala De Henares
- Cádiz
- Castellon
- Madrid
- Malaga
- Palma de Mallorca
- Sagunto
- San Sebastian
- Valencia
- Valladolid
- Zamora
