An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.

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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

Aurangabad, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients, >/= 18 years of age
Advanced and/or metastatic renal cell carcinoma
Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
At least one measurable and non-measurable lesion according to RECIST criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow, renal and liver function

Exclusion criteria

Contraindications to Avastin and/or interferon alpha-2a as per local label

Treatment and study plan

Primary outcomes

Safety: Incidence of adverse events

Time frame: approximately 4 years

Secondary outcomes

Progression-free survival: time from first drug administration to documented disease progression or death of any cause

Time frame: approximately 4 years
Overall response rate: complete response or partial response according to RECIST criteria

Time frame: approximately 4 years
Overall survival

Time frame: approximately 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 11, 2011
Registry last updated: Oct 4, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed