Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

NCT ID: NCT00193258

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2011-08-31

Brief Summary

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Detailed Description

Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib + Imatinib

A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Conditions

Clear Cell Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

In the phase I portion:

Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course

Erlotinib 150 mg orally daily

Imatinib 300 mg orally daily or 400 mg orally daily

In the phase II portion:

Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle

Erlotinib 150 mg orally daily

Imatinib 400 mg orally daily

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

10mg/kg IV infusion every 2 weeks

Erlotinib

Intervention Type: DRUG

150 mg po daily

Imatinib

Intervention Type: DRUG

400-600mg daily

Interventions

Bevacizumab

10mg/kg IV infusion every 2 weeks

Intervention Type: DRUG

Erlotinib

150 mg po daily

Intervention Type: DRUG

Imatinib

400-600mg daily

Intervention Type: DRUG

Other Intervention Names

Avastin; Tarceva; STI571, Gleevec, Glivec, imatinib mesilate (INN)

Eligibility Criteria

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
• Previous nephrectomy is required
• Maximum of 1 previous systemic regimen for metastatic disease.
• Able to perform activities of daily living with minimal assistance
• Measurable disease
• Adequate bone marrow, liver and kidney
• Written informed consent.

Exclusion Criteria

• Age < 18 years
• Treatment with more than 1 previous systemic regimen
• History of heart attack within 6 months
• Clinically significant cardiovascular disease
• Moderate to severe vascular disease.
• Active brain metastases.
• History or evidence by physical examination of brain tumor
• Seizures not controlled with standard medical therapy
• history of stroke or other serious disorders of the nervous system
• Clinical history of coughing or vomiting blood within the past 3 months.
• PEG tubes or G tubes
• Chronic therapy with NSAIDS or other platelet inhibitors
• Proteinuria
• Nonhealing wound, ulcer, or long bone fracture
• Clinical evidence or history of a bleeding disorder
• Requiring full dose anticoagulation with coumadin
• Receiving chronic steroid therapy
• Significant medical conditions.
• Tumors other than clear cell
• History of stroke within 6 months.
• History of abdominal fistula,perforation,or abscess within 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030.

Reference Type: RESULT

PMID: 18272024 (View on PubMed)

Related Links

http://cigjournals.metapress.com/content/78747811327l1q78/?p=add93b1605a842cb946ca178813c9b17&pi=2

Published article in Clinical Genitourinary Cancer

Other Identifiers

SCRI GU 22

Identifier Type: -

Identifier Source: org_study_id