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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193258
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : January 14, 2013
Last Update Posted : January 31, 2013
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

September 12, 2005
September 19, 2005
December 7, 2012
January 14, 2013
January 31, 2013
June 2004
January 2011   (Final data collection date for primary outcome measure)
  • Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]
    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.
  • 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 [ Time Frame: 18 months ]
  • Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 24 months ]
Objective response rate.
Complete list of historical versions of study NCT00193258 on Archive Site
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  • Progression-free survival
  • Overall survival.
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Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma
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.

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.

Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Clear Cell Renal Cell Carcinoma
  • Drug: Bevacizumab
    10mg/kg IV infusion every 2 weeks
    Other Name: Avastin
  • Drug: Erlotinib
    150 mg po daily
    Other Name: Tarceva
  • Drug: Imatinib
    400-600mg daily
    Other Name: STI571, Gleevec, Glivec, imatinib mesilate (INN)
Experimental: 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

  • Drug: Bevacizumab
  • Drug: Erlotinib
  • Drug: Imatinib
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2011
January 2011   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
  • Genentech, Inc.
  • Novartis
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP