Back to resultsA Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bevacizumab [Avastin]
Platinum-based chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Rate of grade >=3 Avastin-related pulmonary hemorrhage
Secondary Outcome Measures
Overall response, duration of response, progression-free survival.
AEs, laboratory parameters, coagulation parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404703
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Primary (safety) endpoint reached
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
15mg iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
Platinum-based chemotherapy
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Rate of grade >=3 Avastin-related pulmonary hemorrhage
Time Frame
After a maximum of 12 months treatment
Secondary Outcome Measure Information:
Title
Overall response, duration of response, progression-free survival.
Time Frame
Event driven
Title
AEs, laboratory parameters, coagulation parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Tugun
Country
Australia
City
Wollongong
Country
Australia
City
Liege
Country
Belgium
City
Ostrava
Country
Czech Republic
City
Usti nad Labem
Country
Czech Republic
City
Bobigny
Country
France
City
Marseille
Country
France
City
Nantes
Country
France
City
Szekesfehervar
Country
Hungary
City
Szombathely
Country
Hungary
City
Kfar Saba
Country
Israel
City
Ramat Gan
Country
Israel
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Balashikha
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Madrid
Country
Spain
City
Sevilla
Country
Spain
City
Kueishan
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
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