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

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ClinicalTrials.gov Identifier: NCT00764972
Recruitment Status : Unknown
Verified October 2008 by McGill University.
Recruitment status was:  Recruiting
First Posted : October 2, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Sorafenib and Vinorelbine Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer
Study Start Date : October 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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 Name: BAY 43-9006


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764972


Contacts
Contact: Lawrence Panasci 514-340-8248 lpanasci@hotmail.com
Contact: Cristiano Ferrario 514-340-8248 cristianoferrario@gmail.com

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Lawrence Panasci    514-340-8248    lpanasci@hotmail.com   
Contact: Cristiano Ferrario    514-340-8248    cristianoferrario@gmail.com   
Principal Investigator: Lawrence Panasci         
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Lawrence Panasci McGill University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cristina Attard, BSc Oncology Project Specialist, Bayer HealthCare Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00764972     History of Changes
Other Study ID Numbers: McG 0713
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by McGill University:
To evaluate the use of sorafenib added to vinorelbine chemotherapy, to find out which are the doses of two drugs can be safely combined

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sorafenib
Vinorelbine
Vinblastine
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators