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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193154
First received: September 12, 2005
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Kidney Cancer
Drug: OSI-774
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Efficacy of the combination of Tarceva and Avastin [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall tolerability and toxicity of this combination regimen [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: February 2003
Study Completion Date: March 2014
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193154

Locations
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
AstraZeneca
Genentech, Inc.
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193154     History of Changes
Other Study ID Numbers: SCRI GU 17, AVF2488s
Study First Received: September 12, 2005
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Kidney Cancer

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

ClinicalTrials.gov processed this record on October 20, 2014