A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma

May 14, 2014 updated by: Genentech, Inc.

A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma

The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Group
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • UCHSC - Urologic Oncology
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Bennett Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Lynn Regional Cancer Center - West
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University / Harper University Hospital
    • Missouri
      • St. Joseph, Missouri, United States, 64507
        • St. Joseph Oncology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center at Hackensack University Medical Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10016
        • NYU School of Medicine
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Northwestern Carolina Oncology & Hematology
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Hematology Oncology
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19004
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Histologically confirmed RCC of clear cell histology
  • Confirmed metastatic RCC
  • Age >=18 years
  • ECOG performance status of 0 or 1
  • Life expectancy >=3 months
  • Prior nephrectomy
  • Measurable disease, as defined by RECIST
  • Use of an acceptable means of contraception (potentially fertile men and women)

Exclusion Criteria:

  • RCC with predominantly sarcomatoid features
  • Prior systemic or adjuvant therapy for RCC
  • Prior radiotherapy for RCC within 28 days prior to Day 0, with the exception of single fraction radiotherapy given for the indication of pain control
  • Treatment with Avastin, Tarceva, or other agents, either investigational or marketed, that act by either EGFR inhibition or anti-angiogenesis mechanisms
  • 24-hour urine collection with >=1 g of protein
  • INR >=1.5, except for subjects receiving warfarin therapy
  • Serum creatinine >2.0 mg/dL
  • Serum calcium >10 mg/dL (corrected)
  • Absolute neutrophil count (ANC) <1500/uL
  • Platelet count <75,000/uL
  • Total bilirubin >2.0 mg/dL
  • AST or ALT >5× the upper limit of normal (ULN) for subjects with documented liver metastases; >2.5 × ULN for subjects without evidence of liver metastases
  • LDH >1.5× ULN
  • Hemoglobin <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
  • History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >160/110 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible), or Grade II or greater peripheral vascular disease
  • History of acute stroke within 6 months prior to randomization
  • Patients on dialysis
  • Other invasive malignancies, including bladder cancer and low-grade endometrial cancer, within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
  • Pregnancy or breast feeding
  • Inability to comply with study and/or follow-up procedures
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
  • Serious, non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • History or clinical evidence of central nervous system or brain metastases
  • History of bowel or gastric perforation

  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study

    • Fine needle aspirations or core biopsies within 7 days prior to Day 0

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVF2938g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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