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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193154

Enrollment

Registered

2005-09-19

Start date

2003-02-28

Completion date

2014-03-31

Last updated

2014-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

Kidney Cancer

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

Interventions

DRUGOSI-774

150mg PO, days 1-28, cycle repeated every 28 days

DRUGBevacizumab

10mg/kg, IV infusion, Days 1 and 15, 28 day cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Efficacy of the combination of Tarceva and Avastin	18 months

Secondary

Measure	Time frame
Objective response rate	18 months
Progression-free survival	18 months
Overall Survival	18 months
Overall tolerability and toxicity of this combination regimen	18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026