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

Kidney Cancer Clinical Trial

Official title:

A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193154
• Other study ID #: SCRI GU 17
• Secondary ID: AVF2488s
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 31, 2014
• Start date: February 2003
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2014
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• OSI-774
150mg PO, days 1-28, cycle repeated every 28 days
• Bevacizumab
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles

Locations

Country	Name	City	State
United States	Medical Oncology LLC	Baton Rouge	Louisiana
United States	Grand Rapids Oncology Program	Grand Rapids	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	AstraZeneca, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2005 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the combination of Tarceva and Avastin		18 months	No
Secondary	Objective response rate		18 months	No
Secondary	Progression-free survival		18 months	No
Secondary	Overall Survival		18 months	No
Secondary	Overall tolerability and toxicity of this combination regimen		18 months	Yes

External Links

•   Published article in the Journal of Clinical Oncology