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Completed

NCT Number: NCT02627144

Bevacizumab in Metastatic Renal Cancer

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.

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Key information

Conditions

Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Freiburg im Breisgau, 79106, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Bevacizumab

Drug

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 names: Avastin

Interferon alpha-2a

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

AVASTIN® First Line in Metastatic Renal Cancer

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2015
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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