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Sorafenib and Vinorelbine in Treating Women With Stage IV Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: January 22, 2009   Last Updated: June 23, 2009   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00828074
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with vinorelbine may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with vinorelbine and to see how well they work in treating women with stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: sorafenib tosylate
Drug: vinorelbine ditartrate
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Recommended phase II dose [ Designated as safety issue: No ]
  • Progression-free survival rate at 4 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity profile [ Designated as safety issue: Yes ]

Estimated Enrollment: 47
Study Start Date: November 2008
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the safety, tolerability, and recommended phase II dose of sorafenib tosylate when administered in combination with vinorelbine ditartrate in women with stage IV adenocarcinoma of the breast. (Phase I)
  • To evaluate the 4-month progression-free survival rate in patients treated with this regimen at the maximum tolerated dose. (Phase II)

Secondary

  • To determine time to treatment failure in these patients.
  • To determine the response rate in these patients.
  • To determine the overall survival and progression-free survival of these patients.
  • To evaluate the toxicity profile of this regimen.

OUTLINE: This is a phase I, dose-escalation study of sorafenib tosylate followed by a phase II study.

Patients receive oral sorafenib tosylate on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Stage IV disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
  • No known brain metastases

    • Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver involvement)
  • Creatinine ≤ 1.5 times ULN
  • INR < 1.5 OR PT/PTT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 weeks after completion of study treatment
  • No HIV positivity
  • No chronic hepatitis B or C infection
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection > CTCAE grade 2
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 6 months
    • Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
    • Psychiatric illness/social situation that would limit compliance with study requirements
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
  • No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
  • No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
  • No serious non-healing wound, ulcer, or bone fracture
  • No evidence or history of bleeding diathesis or coagulopathy
  • No condition that impairs the ability to swallow whole pills
  • No malabsorption problems
  • No known or suspected allergy to sorafenib tosylate or any other agent given in the study
  • No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • Prior adjuvant therapy for metastatic disease allowed
  • No more than 2 lines of prior chemotherapy for metastatic disease (including trastuzumab [Herceptin®]-containing regimens for patients with HER2+ tumors)
  • Prior hormonal therapy allowed
  • Prior bevacizumab administered within the past 4 weeks allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 4 weeks since prior major surgery or open biopsy
  • No prior sunitinib malate
  • No concurrent St. John's wort or rifampin
  • No other concurrent investigational agents
  • Concurrent anticoagulation therapy (e.g., warfarin or heparin) allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828074

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
City of Hope Medical Group Recruiting
Pasadena, California, United States, 91105
Contact: Mark V. McNamara, MD     626-396-2900     mmcnamara@ccsmg.com    
Sponsors and Collaborators
Beckman Research Institute
Investigators
Principal Investigator: Thehang H. Luu, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Comprehensive Cancer Center ( Thehang H. Luu )
Study ID Numbers: CDR0000632806, CHNMC-08103, BAYER-CHNMC-08103
Study First Received: January 22, 2009
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00828074     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
Vinorelbine
Skin Diseases
Tubulin Modulators
Breast Neoplasms
Vinblastine
Antimitotic Agents
Protein Kinase Inhibitors
Antineoplastic Agents, Phytogenic
Sorafenib
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Vinblastine
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Tubulin Modulators
Sorafenib
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009