Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer

October 17, 2008 updated by: McGill University

A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer

This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer.

The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients.

Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence Panasci

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

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women affected by histologically proven metastatic breast cancer.
  • Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.
  • Female, age ≥ 18.
  • Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.
  • ECOG performance status 0-1 (see Appendix B)
  • Life expectancy > 6 months.

  • Adequate bone marrow function, as indicated by:

    • Hemoglobin ≥ 90 g/L
    • Neutrophils ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
  • Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal and/or Creatinine Clearance calculated as >50% lower normal limit, or estimated as ≥ 50 ml/min (Appendix C).

  • Adequate liver function, as indicated by:

    • bilirubin ≤ 1.5 times upper normal limit;
    • AST and ALT ≤ 2 times upper normal limit.
  • Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).
  • No therapy for breast cancer in the 4 weeks preceding the therapy start.
  • Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
  • Patient able to understand and give written informed consent.

Exclusion Criteria:

  • Patients with locally advanced breast cancer or stage IIIb only.
  • Presence of only non-measurable disease.
  • Previous (neo)adjuvant chemotherapy with vinorelbine.
  • Any previous anti-angiogenic therapy.
  • Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.
  • Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.
  • Major surgery within 4 weeks of first study treatment, or minor surgery (including placement of an access device) within 7 days of therapy start.
  • Presence of life-threatening disease or central nervous system localizations.
  • Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification or score 3+ by immunohistochemistry.
  • Any other possibly active primary tumor, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Clinically significant hepatic disease with respect to hepatitis B, hepatitis C, cirrhosis or other liver diseases.
  • Uncontrolled bacterial, viral or fungal infection.
  • Previous history of ischemic disease.
  • Patients with previous history of thrombo-embolic events, or with documented risk factors for thrombotic disease other than cancer.
  • History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria requiring medical intervention).
  • Uncontrolled hypertension.
  • Other serious medical conditions, such as uncontrolled cardiac disease, severe pulmonary disease, uncontrolled diabetes.
  • Patient exhibiting confusion or disorientation.
  • Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.
  • Patient is pregnant, or is breast-feeding, or is unwilling to use adequate contraception.
  • Failure to give informed consent.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib and Vinorelbine
Drug: Sorafenib and Vinorelbine

vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles);

sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe.

Other Names:
  • BAY 43-9006

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.

Collaborators and Investigators

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

Sponsor

McGill University

Investigators

  • Principal Investigator: Lawrence Panasci, McGill University

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

October 1, 2007

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • McG 0713

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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