Back to resultsA Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Primary Purpose
Renal Cell Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
bevacizumab [Avastin]
Interferon alfa-2a
Vinblastine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- metastatic renal cell cancer of predominantly clear cell type;
- >=1 measurable lesion.
Exclusion Criteria:
- prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
- ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
- clinically significant cardiovascular disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Disease Progression or Death
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
PFS - Time to Event
PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method
Secondary Outcome Measures
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.
Overall Survival (OS)
OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00520403
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Official Title
An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 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 efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell 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
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
15mg/kg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Interferon alfa-2a
Intervention Description
3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
0.1mg/kg iv every 3 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression or Death
Description
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
Time Frame
Days 0, 91, 182, 273, 365, 456, and 547
Title
PFS - Time to Event
Description
PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method
Time Frame
Days 0, 91, 182, 273, 365, 456, and 547
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR)
Description
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.
Time Frame
Baseline and Cycles 3, 6, 9, 13, and 17
Title
Overall Survival (OS)
Description
OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.
Time Frame
Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)
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;
metastatic renal cell cancer of predominantly clear cell type;
>=1 measurable lesion.
Exclusion Criteria:
prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
clinically significant cardiovascular disease.
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
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10967
Country
Germany
City
Bremen
ZIP/Postal Code
28277
Country
Germany
City
Dessau
ZIP/Postal Code
06846
Country
Germany
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Halle
ZIP/Postal Code
06097
Country
Germany
City
Hannover
ZIP/Postal Code
30449
Country
Germany
City
Jena
ZIP/Postal Code
07743
Country
Germany
City
Kassel
ZIP/Postal Code
34125
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
City
Rehling
ZIP/Postal Code
86058
Country
Germany
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
City
Weiden
ZIP/Postal Code
92637
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
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