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

This study has been terminated.
(new methods of treatment, no more patients appilicable for study)
Sponsor:
Collaborators:
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
GlaxoSmithKline
Information provided by (Responsible Party):
Sponsor GmbH
ClinicalTrials.gov Identifier:
NCT01238029
First received: November 2, 2010
Last updated: November 20, 2014
Last verified: November 2014
  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

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:


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:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 12
Study Start Date: October 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238029

Locations
Germany
Onkologie Ravensburg
Ravensburg, Baden-Württemberg, Germany, 88214
Praxisgemeinschaft Dres. Siehl und Söling
Kassel, Hessen, Germany, 34117
Onkologische Schwerpunktpraxis
Goslar, Niedersachsen, Germany, 38642
Onkologische Schwerpunktpraxis Leer Emden
Leer, Niedersachsen, Germany, 26789
Schwerpunktpraxis Hämatologie / Onkologie
Stade, Niedersachsen, Germany, 21680
Onkodok (Dr. Rösel und Dr. Depenbusch)
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Praxis für Hämatologie und Onkologie
Mulheim an der Ruhr, Nordrhein-Westfalen, Germany, 45468
Hämatologisch-onkologische Gemeinschaftspraxis
Münster, Nordrhein-Westfalen, Germany, 48149
Praxis für Onkologie u. Hämatologie
Neuss, Nordrhein-Westfalen, Germany, 41462
Onkologische Gemeinschaftspraxis Dörfel/Göhler
Dresden, Saxony, Germany, 01127
Onkologische Schwerpunktpraxis
Heidelberg, Germany, 69115
Sponsors and Collaborators
Sponsor GmbH
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
GlaxoSmithKline
Investigators
Principal Investigator: Ulrike Soeling, MD Goethestr. 47, 34119 , Kassel, Germany
  More Information

No publications provided

Responsible Party: Sponsor GmbH
ClinicalTrials.gov Identifier: NCT01238029     History of Changes
Other Study ID Numbers: 0907-002
Study First Received: November 2, 2010
Last Updated: November 20, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Lapatinib
Vinblastine
Vinorelbine
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014