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Bevacizumab in Metastatic Renal Cancer

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ClinicalTrials.gov Identifier: NCT02627144
Recruitment Status : Completed
First Posted : December 10, 2015
Results First Posted : July 12, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.

Condition or disease Intervention/treatment
Renal Cell Cancer Drug: Bevacizumab Drug: Interferon alpha-2a

Study Design
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Study Type : Observational
Actual Enrollment : 365 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: AVASTIN® First Line in Metastatic Renal Cancer
Study Start Date : January 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Advanced and/or Metastatic RCC participants
Participants with mRCC who are being treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression will be observed. No diagnostic or therapeutic interventions will be given other than used in normal daily routine.
 Drug: Bevacizumab
Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.
Other Name: Avastin

Drug: Interferon alpha-2a
Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Best Overall Tumor Response [ Time Frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years ]
    Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

  2. Percentage of Participants With Disease Control [ Time Frame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years ]
    Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

  3. Progression-free Survival (PFS) Time [ Time Frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years ]
    PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.

  4. Overall Survival (OS) Time [ Time Frame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years ]
    OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

  5. Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine [ Time Frame: Up to 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with advanced and/or metastatic renal cell cancer
Criteria

Inclusion Criteria:

  • Histologically confirmed advanced and/or metastatic renal cell cancer
  • No contraindications for Avastin according to summary of product characteristics (SmPC)

Exclusion Criteria:

-

Contacts and Locations
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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): NCT02627144


Locations
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Germany
Freiburg, Germany, 79106
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02627144    
Other Study ID Numbers: ML21519
First Posted: December 10, 2015    Key Record Dates
Results First Posted: July 12, 2016
Last Update Posted: August 29, 2016
Last Verified: July 2016
Keywords provided by Hoffmann-La Roche:
Metastatic renal cell carcinoma
Avastin
Bevacizumab
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferons
 Interferon-alpha
Interferon alpha-2
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antiviral Agents
Anti-Infective Agents
Immunologic Factors