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

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193258
• Other study ID #: SCRI GU 22
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2013
• Start date: June 2004
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Drug:
• Bevacizumab
10mg/kg IV infusion every 2 weeks
• Erlotinib
150 mg po daily
• Imatinib
400-600mg daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc., Novartis

References & Publications (1)

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 Genito — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	18 months	No
Primary	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease		18 months	No
Primary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death		24 months	No