A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC)


Tracking Information

Start Date  ICMJEDecember 2008
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: November 21, 2008)		Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00796757 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 21, 2008)		Objective response rate; overall survival; NCI-CTC Grade 3-5 adverse event rate until disease progression; overall adverse event rate and serious adverse event rate until disease progression. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Official Title  ICMJEAn Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.
Brief Summary

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJERenal Cell Cancer
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    10mg/kg iv infusion every 2 weeks
  • Drug: interferon alfa-2a
    3 MIU sc t.i.w.
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: interferon alfa-2a

Recruitment Information

Estimated Enrollment  ICMJE140
Estimated Completion DateApril 2013
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • metastatic RCC with majority (>50%) of conventional clear-cell type;
  • prior total nephrectomy for primary RCC;
  • at least one measurable or non-measurable lesions;
  • ECOG performance score of 0 or 2.

Exclusion Criteria:

  • prior systemic treatment for metastatic RCC;
  • current or previously treated but non-stable CNS metastases or spinal cord compression;
  • major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
  • significant cardiovascular disease within 6 months prior to enrollment.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MO21609888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJECzech Republic,   Estonia,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Netherlands,   Russian Federation,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00796757
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMO21609, 2007-006611-23
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche