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

SCRI Development Innovations

Status and phase: Completed; Phase 2; Phase 1

Conditions: Clear Cell Renal Cell Carcinoma

Treatments: Drug: Erlotinib; Drug: Bevacizumab; Drug: Imatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193258

SCRI GU 22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

94 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Imatinib

Drug: Bevacizumab

Drug: Erlotinib