A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00520403
First received: August 23, 2007
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Cancer |
Drug: bevacizumab [Avastin] Drug: Interferon alfa-2a Drug: Vinblastine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Vinblastine sulfate
Vinblastine
Interferon
Interferon Alfa-2a
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Median progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tumor assessment (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: Interferon alfa-2a
3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
Drug: Vinblastine
0.1mg/kg iv every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520403
Locations
| Germany | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, 10967 | |
| Bremen, Germany, 28277 | |
| Dessau, Germany, 06846 | |
| Erlangen, Germany, 91052 | |
| Frankfurt, Germany, 60596 | |
| Halle, Germany, 06097 | |
| Hannover, Germany, 30449 | |
| Jena, Germany, 07743 | |
| Kassel, Germany, 34125 | |
| Kiel, Germany, 24105 | |
| Leipzig, Germany, 04103 | |
| Magdeburg, Germany, 39120 | |
| Rehling, Germany, 86058 | |
| Stuttgart, Germany, 70174 | |
| Weiden, Germany, 92637 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00520403 History of Changes |
| Other Study ID Numbers: | ML19983 |
| Study First Received: | August 23, 2007 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Germany: Landesamt fur Gesundheit und Soziales Berlin |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Bevacizumab Vinblastine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators |
ClinicalTrials.gov processed this record on June 18, 2013