search
Back to results

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

Primary Purpose

Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Lapatinib and Capecitabine and Vinorelbine
Sponsored by
Sponsor GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Dose finding study, Combination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Onkologie Ravensburg
  • Praxisgemeinschaft Dres. Siehl und Söling
  • Onkologische Schwerpunktpraxis
  • Onkologische Schwerpunktpraxis Leer Emden
  • Schwerpunktpraxis Hämatologie / Onkologie
  • Onkodok (Dr. Rösel und Dr. Depenbusch)
  • Praxis für Hämatologie und Onkologie
  • Hämatologisch-onkologische Gemeinschaftspraxis
  • Praxis für Onkologie u. Hämatologie
  • Onkologische Gemeinschaftspraxis Dörfel/Göhler
  • Onkologische Schwerpunktpraxis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine, Lapatinib, Vinorelbine

Arm Description

Outcomes

Primary Outcome Measures

Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
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
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Progression free survival
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)
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Overall survival (OS)
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

Full Information

First Posted
November 2, 2010
Last Updated
November 20, 2014
Sponsor
Sponsor GmbH
Collaborators
iOMEDICO AG, Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT01238029
Brief Title
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
Acronym
CELAVIE
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
new methods of treatment, no more patients appilicable for study
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sponsor GmbH
Collaborators
iOMEDICO AG, Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy, Failure or Contraindication of Trastuzumab Therapy
Keywords
Dose finding study, Combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine, Lapatinib, Vinorelbine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lapatinib and Capecitabine and Vinorelbine
Other Intervention Name(s)
Xeloda, Tyverb, Navirel
Intervention Description
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
Primary Outcome Measure Information:
Title
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
Description
Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Overall response Rate
Description
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Time Frame
12 months
Title
Progression free survival
Description
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Time Frame
12 months
Title
Time to treatment failure (TTF)
Description
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Time Frame
12 months
Title
Overall survival (OS)
Description
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Soeling, MD
Organizational Affiliation
Goethestr. 47, 34119 , Kassel, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onkologie Ravensburg
City
Ravensburg
State/Province
Baden-Württemberg
ZIP/Postal Code
88214
Country
Germany
Facility Name
Praxisgemeinschaft Dres. Siehl und Söling
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34117
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Goslar
State/Province
Niedersachsen
ZIP/Postal Code
38642
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Leer Emden
City
Leer
State/Province
Niedersachsen
ZIP/Postal Code
26789
Country
Germany
Facility Name
Schwerpunktpraxis Hämatologie / Onkologie
City
Stade
State/Province
Niedersachsen
ZIP/Postal Code
21680
Country
Germany
Facility Name
Onkodok (Dr. Rösel und Dr. Depenbusch)
City
Guetersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Facility Name
Praxis für Hämatologie und Onkologie
City
Mulheim an der Ruhr
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45468
Country
Germany
Facility Name
Hämatologisch-onkologische Gemeinschaftspraxis
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Praxis für Onkologie u. Hämatologie
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41462
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis Dörfel/Göhler
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01127
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs