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Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

This study has been withdrawn prior to enrollment.
(Poor accrual)
Sponsor:
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00754702
First received: September 17, 2008
Last updated: July 20, 2011
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
 Drug: Vinorelbine
Drug: Lapatinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of Crete:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 3 - 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vinorelbine metronomic/Lapatinib
 Drug: Vinorelbine
Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
Other Name: Navelbine
Drug: Lapatinib
Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity
Other Names:
  • Tyverb
  • Tykerb

Detailed Description:

Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
  • Age 18-75 years
  • HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
  • Previous therapies had to include, regimens containing an anthracycline and a taxane
  • Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver (serum bilirubin <1.5 times the upper normal limit; AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

Exclusion Criteria:

  • Patient unable to take oral medication
  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • Other invasive malignancy except nonmelanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754702

Locations
Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Dimitris Mavrudis, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00754702     History of Changes
Other Study ID Numbers: CT/08.27
Study First Received: September 17, 2008
Last Updated: July 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by University Hospital of Crete:
Vinorelbine metronomic-lapatinib
Chemotherapy
Targeted therapy

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

ClinicalTrials.gov processed this record on May 22, 2013