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

Phase 1/Phase 2
18 Years
Not Enrolling
Clear Cell Renal Cell Carcinoma

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

August 2011

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Recurrent clear cell renal cell carcinoma
  • Bevacizumab
  • Erlotinib
  • Imatinib
  • Carcinoma
  • Carcinoma, Renal Cell