A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00796757
First received: November 21, 2008
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Renal Cell Cancer
Drug: bevacizumab [Avastin]
Drug: interferon alfa-2a
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 of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate; overall survival; NCI-CTC Grade 3-5 adverse event rate until disease progression; overall adverse event rate and serious adverse event rate until disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: December 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
Drug: interferon alfa-2a
3 MIU sc t.i.w.

  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 RCC with majority (>50%) of conventional clear-cell type;
  • prior total nephrectomy for primary RCC;
  • at least one measurable or non-measurable lesions;
  • ECOG performance score of 0 or 2.

Exclusion Criteria:

  • prior systemic treatment for metastatic RCC;
  • current or previously treated but non-stable CNS metastases or spinal cord compression;
  • major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
  • significant cardiovascular disease within 6 months prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796757

  Hide Study Locations
Locations
Czech Republic
Olomouc, Czech Republic, 775 20
Praha 2, Czech Republic, 128 08
Estonia
Tallinn, Estonia, 10617
Tallinn, Estonia, 13419
Tartu, Estonia, 50406
Finland
Seinäjoki, Finland, 60220
Turku, Finland, 20520
Germany
Arnsberg, Germany, 59755
Augsburg, Germany, 86156
Berlin, Germany, 10117
Berlin, Germany, 13055
Freiburg, Germany, 79106
Homburg/Saar, Germany, 66424
Leipzig, Germany, 04103
München, Germany, 81241
Münster, Germany, 48149
Offenburg, Germany, 77652
Planegg, Germany, 82152
Stuttgart, Germany, 70174
Weiden, Germany, 92637
Greece
Larissa, Greece, 41 110
Thessaloniki, Greece, 54639
Thessaloniki, Greece, 56429
Italy
Milano, Italy, 20100
Napoli, Italy, 80131
Pisa, Italy, 56100
Lithuania
Kaunas, Lithuania, 50009
Vilnius, Lithuania, 08661
Netherlands
Amstelveen, Netherlands, 1186 AH
Eindhoven, Netherlands, 5623 EJ
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6525 GA
Russian Federation
Barnaul, Russian Federation, 656049
Ekaterinburg, Russian Federation, 620102
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125284
Obninsk, Russian Federation, 249020
St Petersburg, Russian Federation
UFA, Russian Federation, 450054
Ulyanovsk, Russian Federation, 432063
Sweden
Eskilstuna, Sweden, 63188
Linkoeping, Sweden, 58185
Sundsvall, Sweden, 85186
Vaxjo, Sweden, 35185
Switzerland
Aarau, Switzerland, 5000
Locarno, Switzerland, 6601
Zürich, Switzerland, 8063
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Cardiff, United Kingdom, CF14 2TL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796757     History of Changes
Other Study ID Numbers: MO21609, 2007-006611-23
Study First Received: November 21, 2008
Last Updated: October 17, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferons
Bevacizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014