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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351571
First received: May 9, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational study will evaluate the safety and efficacy of Avastin (bevac izumab) in combination with interferon alpha-2a as first-line treatment in patie nts with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient for up to 4 years.


Condition
Renal Cell Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival: time from first drug administration to documented disease progression or death of any cause [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall response rate: complete response or partial response according to RECIST criteria [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with advanced and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a

Criteria

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
  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: NCT01351571

Locations
India
Aurangabad, India, 35
Delhi, India, 110085
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: NCT01351571     History of Changes
Other Study ID Numbers: ML25251
Study First Received: May 9, 2011
Last Updated: July 7, 2014
Health Authority: India: Directorate General of Health Services - Drugs Controller General

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

ClinicalTrials.gov processed this record on July 31, 2014