Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma

NCT00556205 | Withdrawn Phase 2

• 1 other identifier: 07-202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.

Conditions

Renal Cell Carcinoma

Keywords

mRCC; sunitinib; bevacizumab

Outcome Measures

Primary Outcomes (1)

• To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.

  Until tumor progression

Secondary Outcomes (3)

• To determine the overall response rate in this patient population.

  Until tumor progression

• To evaluate the safety and tolerability of these treatments in mRCC patients with disease progression on standard dose sunitinib.

  Until tumor progression

• To collect serum research samples for analysis of predictive biomarkers of response.

  Two months

Study Arms (2)

1

ACTIVE COMPARATOR

Bevacizumab monotherapy 10 mg/kg IV q2 weeks

Drug: Bevacizumab

2

ACTIVE COMPARATOR

Combination Sunitinib \& Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule

Drug: Sunitinib; Drug: Bevacizumab

Interventions

Sunitinib DRUG

Sunitinib orally once daily

Also known as: sutent

2

Bevacizumab DRUG

Intravenously every 14 days

Also known as: avastin

1; 2

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed metastatic renal cell carcinoma with clear cell histology
• Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
• Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
• Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
• Participants must have received at least 14 doses of sunitinib therapy
• Participants must enroll within 3 months of the last dose of sunitinib
• Males or females, age of 18 years or older
• ECOG Performance status 0-2
• Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedures to NCI CTCAE version 3.0 grade 1 or less
• Laboratory values as defined in protocol
• weeks or more must have elapsed from the time of major surgery and subjects must have recovered from the procedure prior to day 1 of randomization
• No anticipated need for major surgical procedure during the course of the study
• weeks or more must have elapsed from the time of minor surgery and subjects must have recovered from the procedure prior to day 1 of randomization
• weeks of more must have elapsed from the time of major radiotherapy prior to day 1 of randomization

You may not qualify if:

• Prior treatment with bevacizumab
• Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
• Prior systemic therapy for RCC with \> 2 regimens
• Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
• Uncontrolled high blood pressure
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 3 months prior to day 0
• Any of the following within the 6 months prior to sudy drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, symptomatic congestive heart failure, or ejection fraction \< 30%
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range without medication
• History of or known brain metastases or spinal cord compression
• NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Grade 3 or higher cardiac dysrhythmia or QT prolongation
• Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Pfizer: collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib; Bevacizumab

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• M. Dror Michaelson, MD, PhD

  Massachusetts General Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 24, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share