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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

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


Upon determination of eligibility, all patients will be receive:

Tarceva + Avastin


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of the combination of Tarceva and Avastin

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GU 17

NCT ID:

NCT00193154

Start Date:

February 2003

Completion Date:

October 2013

Related Keywords:

  • Kidney Cancer
  • Kidney Cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Medical Oncology LLCBaton Rouge, Louisiana  70809
Grand Rapids Oncology ProgramGrand Rapids, Michigan  49503