Study Stopped
Primary (safety) endpoint reached
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
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
1 other identifier
interventional
37
10 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Aug 2006
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 28, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedAugust 24, 2016
August 1, 2008
1.5 years
November 28, 2006
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of grade >=3 Avastin-related pulmonary hemorrhage
After a maximum of 12 months treatment
Secondary Outcomes (2)
Overall response, duration of response, progression-free survival.
Event driven
AEs, laboratory parameters, coagulation parameters.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Tugun, Australia
Unknown Facility
Wollongong, Australia
Unknown Facility
Liège, Belgium
Unknown Facility
Ostrava, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Unknown Facility
Bobigny, France
Unknown Facility
Marseille, France
Unknown Facility
Nantes, France
Unknown Facility
Székesfehérvár, Hungary
Unknown Facility
Szombathely, Hungary
Unknown Facility
Kfar Saba, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Lublin, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Balashikha, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Madrid, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Kueishan, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2006
First Posted
November 29, 2006
Study Start
August 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
August 24, 2016
Record last verified: 2008-08