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A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520403
First Posted: August 24, 2007
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Days 0, 91, 182, 273, 365, 456, and 547 ]
    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 [ Time Frame: Days 0, 91, 182, 273, 365, 456, and 547 ]
    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) [ Time Frame: Baseline and Cycles 3, 6, 9, 13, and 17 ]
    Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.

  • Overall Survival (OS) [ Time Frame: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102) ]
    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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00520403     History of Changes
Other Study ID Numbers: ML19983
First Submitted: August 23, 2007
First Posted: August 24, 2007
Results First Submitted: August 14, 2014
Results First Posted: October 13, 2014
Last Update Posted: October 13, 2014
Last Verified: October 2014

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
Bevacizumab
Interferons
Vinblastine
Interferon-alpha
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action