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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00520403
First received: August 23, 2007
Last updated: October 9, 2014
Last verified: October 2014
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

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
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: 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
Results First Received: August 14, 2014
Last Updated: October 9, 2014
Health Authority: Germany: Landesamt fur Gesundheit und Soziales Berlin

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

ClinicalTrials.gov processed this record on October 20, 2014