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OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OSI-774
Bevacizumab
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Oncology LLC
  • Grand Rapids Oncology Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OSI-774 & bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of the combination of Tarceva and Avastin

Secondary Outcome Measures

Objective response rate
Progression-free survival
Overall Survival
Overall tolerability and toxicity of this combination regimen

Full Information

First Posted
September 12, 2005
Last Updated
March 31, 2014
Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00193154
Brief Title
OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Official Title
A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Upon determination of eligibility, all patients will receive: Tarceva + Avastin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
Kidney Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSI-774 & bevacizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
OSI-774
Other Intervention Name(s)
Tarceva
Intervention Description
150mg PO, days 1-28, cycle repeated every 28 days
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
Primary Outcome Measure Information:
Title
Efficacy of the combination of Tarceva and Avastin
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
18 months
Title
Progression-free survival
Time Frame
18 months
Title
Overall Survival
Time Frame
18 months
Title
Overall tolerability and toxicity of this combination regimen
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Oncology LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Grand Rapids Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16204015
Citation
Hainsworth JD, Sosman JA, Spigel DR, Edwards DL, Baughman C, Greco A. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol. 2005 Nov 1;23(31):7889-96. doi: 10.1200/JCO.2005.01.8234. Epub 2005 Oct 3.
Results Reference
result

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OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma

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