A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

Renal Cell Cancer Clinical Trial

Official title:

An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520403
• Other study ID #: ML19983
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2007
• Last updated: October 9, 2014
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: October 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Landesamt fur Gesundheit und Soziales Berlin
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• metastatic renal cell cancer of predominantly clear cell type;

• >=1 measurable lesion.

Exclusion Criteria:

• prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;

• ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);

• clinically significant cardiovascular disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

Intervention

Drug:
• bevacizumab [Avastin]
15mg/kg iv every 3 weeks
• Interferon alfa-2a
3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
• Vinblastine
0.1mg/kg iv every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Disease Progression or Death	Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.	Days 0, 91, 182, 273, 365, 456, and 547	No
Primary	PFS - Time to Event	PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method	Days 0, 91, 182, 273, 365, 456, and 547	No
Secondary	Percentage of Participants With Objective Response (OR)	Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.	Baseline and Cycles 3, 6, 9, 13, and 17	No
Secondary	Overall Survival (OS)	OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.	Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)	No