OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic 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: NCT00193154
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 1, 2014
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: OSI-774 Drug: Bevacizumab Phase 2

Detailed Description:

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Study Start Date : February 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: OSI-774 & bevacizumab
OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.
Drug: OSI-774
150mg PO, days 1-28, cycle repeated every 28 days
Other Name: Tarceva

Drug: Bevacizumab
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
Other Name: Avastin

Primary Outcome Measures :
  1. Efficacy of the combination of Tarceva and Avastin [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 18 months ]
  2. Progression-free survival [ Time Frame: 18 months ]
  3. Overall Survival [ Time Frame: 18 months ]
  4. Overall tolerability and toxicity of this combination regimen [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

  • Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
  • Previous nephrectomy
  • Maximum of 1 previous regimen for metastatic disease
  • Ability to perform activities of daily living with minimal assistance
  • Measurable disease
  • Adequate bone marrow, liver and kidney function
  • Give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • Treatment with more than one previous regimen for metastatic disease
  • Clinically significant cardiovascular disease
  • Active brain metastases
  • History of CNS disease
  • Clinical history of coughing or vomiting blood.
  • History of thromboembolic disease.
  • PEG or G-tube are ineligible.
  • Current use of full dose anticoagulants or thrombolytic agents
  • Chronic daily treatment with aspirin or NSAIDS
  • Any clinical evidence or history of a bleeding or clotting disorder

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193154

United States, Louisiana
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Grand Rapids Oncology Program
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193154     History of Changes
Other Study ID Numbers: SCRI GU 17
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by SCRI Development Innovations, LLC:
Kidney Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action