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Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer (CELAVIE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Sponsor GmbH.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
GlaxoSmithKline
Information provided by:
Sponsor GmbH
ClinicalTrials.gov Identifier:
NCT01238029
First received: November 2, 2010
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
HER2 Positive
First or Second Line Therapy
Failure or Contraindication of Trastuzumab Therapy
 Drug: Lapatinib and Capecitabine and Vinorelbine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sponsor GmbH:

Primary Outcome Measures:
  • Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)


Secondary Outcome Measures:
  • Phase II: Overall response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

  • Phase II: Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

  • Phase II: Time to treatment failure (TTF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

  • Phase II: Overall survival (OS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.


Estimated Enrollment: 36
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine, Lapatinib, Vinorelbine Drug: Lapatinib and Capecitabine and Vinorelbine
Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
Other Names:
  • Xeloda
  • Tyverb
  • Navirel

Detailed Description:

The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.

  Eligibility

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

Key Inclusion Criteria:

  • Written informed consent
  • Able to comply with the protocol
  • ECOG performance status 0-1
  • Adequate contraception
  • Confirmed Her2/neu-positive, adenocarcinoma of the breast
  • At least one measurable lesion according to RECIST 1.1 criteria
  • First or second chemotherapy after diagnosis of metastasis
  • Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
  • No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
  • Adequate hepatic and renal function value
  • Adequate hematologic function values

Exclusion Criteria:

  • Pregnant or lactating women
  • Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
  • Asymptomatic with regards to tumor illness
  • Previous treatment with lapatinib, capecitabine or vinorelbine
  • Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
  • Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
  • History of vascular or cardiovascular disease within the past 6 months
  • All illnesses that result in malabsorption of oral medication or inability to take oral medication
  • Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
  • Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
  • Concurrent treatment with allopurinol
  • Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
  • Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238029

Contacts
Contact: Ulrike Söling, MD 0561 7393372 dr@soeling.de

Locations
Germany
Onkologie Ravensburg Recruiting
Ravensburg, Baden-Württemberg, Germany, 88214
Contact: Thomas Decker, MD     ++49 751- 36650373     t.decker@lrz.tum.de    
Principal Investigator: Thomas Decker, MD            
Praxisgemeinschaft Dres. Siehl und Söling Recruiting
Kassel, Hessen, Germany, 34117
Contact: Ulrike Soeling, MD     ++49 561 7393372     dr@soeling.de    
Principal Investigator: Ulrike Soeling, MD            
Onkologische Schwerpunktpraxis Recruiting
Goslar, Niedersachsen, Germany, 38642
Contact: Hans W Tessen, MD     +49 5321 686 ext 10     paola.goetz@onkologie-goslar.de    
Principal Investigator: Hans W Tessen, MD            
Onkologische Schwerpunktpraxis Leer Emden Recruiting
Leer, Niedersachsen, Germany, 26789
Contact: Lothar Mueller, MD     ++49 491 987910     lothar.mueller@onkologie-leer.de    
Principal Investigator: Lothar Mueller, MD            
Schwerpunktpraxis Hämatologie / Onkologie Recruiting
Stade, Niedersachsen, Germany, 21680
Contact: Claus-Christoph Steffens, MD     ++49 41416040     steffens@onkologie-stade.de    
Principal Investigator: Claus-Christoph Steffens, MD            
Onkodok (Dr. Rösel und Dr. Depenbusch) Recruiting
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Contact: Siegfried Roesel, MD     ++49 5241 8324380     siegfried.roesel@klinikum-guetersloh.de    
Principal Investigator: Siegfried Roesel, MD            
Praxis für Hämatologie und Onkologie Recruiting
Mulheim an der Ruhr, Nordrhein-Westfalen, Germany, 45468
Contact: Jan Schroeder, MD     ++49 208-76981     praxis@onkologie-muelheim.de    
Principal Investigator: Jan Schroeder, MD            
Hämatologisch-onkologische Gemeinschaftspraxis Recruiting
Münster, Nordrhein-Westfalen, Germany, 48149
Contact: Christian Lerchenmueller, MD     ++49 251 620080     lerchenmueller@onkologie-muenster.de    
Principal Investigator: Christian Lerchenmueller, MD            
Praxis für Onkologie u. Hämatologie Recruiting
Neuss, Nordrhein-Westfalen, Germany, 41462
Contact: Christoph Losem, MD     ++49 2131 101206     losem@plelo.de    
Principal Investigator: Christoph Losem, MD            
Onkologische Gemeinschaftspraxis Dörfel/Göhler Active, not recruiting
Dresden, Saxony, Germany, 01127
Onkologische Schwerpunktpraxis Recruiting
Heidelberg, Germany, 69115
Contact: Stefan Fuxius, MD     06221 453281     stefanfuxius@gmx.de    
Principal Investigator: Stefan Fuxius, MD            
Sponsors and Collaborators
Sponsor GmbH
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
GlaxoSmithKline
Investigators
Principal Investigator: Ulrike Soeling, MD Jordanstr. 6, 34117 , Kassel, Germany
  More Information

No publications provided

Responsible Party: Johan Dalm, Deutsche Krebsgesellschaft Sponsor GmbH
ClinicalTrials.gov Identifier: NCT01238029     History of Changes
Other Study ID Numbers: 0907-002
Study First Received: November 2, 2010
Last Updated: November 9, 2010
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sponsor GmbH:
Dose finding study
Combination

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Vinblastine
Capecitabine
Lapatinib
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013