Back to resultsA Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
bevacizumab [Avastin]
cisplatin
vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
- ECOG performance status of 0 or 1;
- no prior thoracic head and neck irradiation or surgical resection for current lung cancer.
Exclusion Criteria:
- mixed, non-small cell and small cell tumors;
- mixed adeno-squamous carcinomas with a predominant squamous component;
- evidence of tumor invasion or encasement of major vessels;
- history of grade >=2 hemoptysis;
- presence of cavitations in lung lesions at baseline.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
Secondary Outcome Measures
Tumor response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00773188
Brief Title
A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
Official Title
A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (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 use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. 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-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5mg/kg iv or 15mg/kg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75mg/m2 iv according to a standard chemotherapy treatment protocol
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Description
15mg/m2 iv according to a standard chemotherapy treatment protocol
Primary Outcome Measure Information:
Title
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Tumor response
Time Frame
Week 13 and Week 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
ECOG performance status of 0 or 1;
no prior thoracic head and neck irradiation or surgical resection for current lung cancer.
Exclusion Criteria:
mixed, non-small cell and small cell tumors;
mixed adeno-squamous carcinomas with a predominant squamous component;
evidence of tumor invasion or encasement of major vessels;
history of grade >=2 hemoptysis;
presence of cavitations in lung lesions at baseline.
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
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
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