Clinical trial NCT01238029: Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
HER2 Positive
First or Second Line Therapy
Failure or Contraindication of Trastuzumab Therapy
Keywords: Dose finding study
Combination
Lead sponsor: Sponsor GmbH
Sponsor class: OTHER
Collaborators: name: iOMEDICO AG
name: Arbeitsgemeinschaft fur Internistische Onkologie
name: Arbeitskreis Klinische Studien
name: GlaxoSmithKline
First posted: 2010-11-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
timeFrame: 4 months
Secondary outcomes:
measure: Overall response Rate
timeFrame: 12 months
measure: Progression free survival
timeFrame: 12 months
measure: Time to treatment failure (TTF)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Ravensburg
country: Germany
facility: Onkologie Ravensburg
state: Baden-Württemberg
city: Kassel
country: Germany
facility: Praxisgemeinschaft Dres. Siehl und Söling
state: Hessen
city: Goslar
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Niedersachsen
city: Leer
country: Germany
facility: Onkologische Schwerpunktpraxis Leer Emden
state: Niedersachsen
city: Stade
country: Germany
facility: Schwerpunktpraxis Hämatologie / Onkologie
state: Niedersachsen
city: Guetersloh
country: Germany
facility: Onkodok (Dr. Rösel und Dr. Depenbusch)
state: Nordrhein-Westfalen
city: Mulheim an der Ruhr
country: Germany
facility: Praxis für Hämatologie und Onkologie
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Hämatologisch-onkologische Gemeinschaftspraxis
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: Praxis für Onkologie u. Hämatologie
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Onkologische Gemeinschaftspraxis Dörfel/Göhler
state: Saxony
city: Heidelberg
country: Germany
facility: Onkologische Schwerpunktpraxis
Study officials:
affiliation: Goethestr. 47, 34119 , Kassel, Germany
name: Ulrike Soeling, MD
role: PRINCIPAL_INVESTIGATOR
References: