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

NCT00520403 | Completed Phase 2 Results

• 1 other identifier: ML19983
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Percentage of Participants With Objective Response (OR)

  Baseline and Cycles 3, 6, 9, 13, and 17

• Overall Survival (OS)

  Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: Interferon alfa-2a; Drug: Vinblastine

Interventions

bevacizumab [Avastin] DRUG

15mg/kg iv every 3 weeks

1

Interferon alfa-2a DRUG

3 MioIU sc escalating to 18 MioIU sc, 3 times weekly

1

Vinblastine DRUG

0.1mg/kg iv every 3 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• metastatic renal cell cancer of predominantly clear cell type;
• \>=1 measurable lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Berlin, 10967, Germany

Location

Unknown Facility

Bremen, 28277, Germany

Location

Unknown Facility

Dessau, 06846, Germany

Location

Unknown Facility

Erlangen, 91052, Germany

Location

Unknown Facility

Frankfurt, 60596, Germany

Location

Unknown Facility

Halle, 06097, Germany

Location

Unknown Facility

Hanover, 30449, Germany

Location

Unknown Facility

Jena, 07743, Germany

Location

Unknown Facility

Kassel, 34125, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Leipzig, 04103, Germany

Location

Unknown Facility

Magdeburg, 39120, Germany

Location

Unknown Facility

Rehling, 86058, Germany

Location

Unknown Facility

Stuttgart, 70174, Germany

Location

Unknown Facility

Weiden, 92637, Germany

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Bevacizumab; Interferon alpha-2; Vinblastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 13, 2014
• Results First Posted: October 13, 2014

Record last verified: 2014-10

Locations

DE (16)