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

Metastatic Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238029
• Other study ID #: 0907-002
• Status: Terminated
• Phase: Phase 1
• First received: November 2, 2010
• Last updated: November 20, 2014
• Start date: October 2010
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Sponsor GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure or Contraindication of Trastuzumab Therapy
• First or Second Line Therapy
• HER2 Positive
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	Onkologische Gemeinschaftspraxis Dörfel/Göhler	Dresden	Saxony
Germany	Onkologische Schwerpunktpraxis	Goslar	Niedersachsen
Germany	Onkodok (Dr. Rösel und Dr. Depenbusch)	Guetersloh	Nordrhein-Westfalen
Germany	Onkologische Schwerpunktpraxis	Heidelberg
Germany	Praxisgemeinschaft Dres. Siehl und Söling	Kassel	Hessen
Germany	Onkologische Schwerpunktpraxis Leer Emden	Leer	Niedersachsen
Germany	Praxis für Hämatologie und Onkologie	Mulheim an der Ruhr	Nordrhein-Westfalen
Germany	Hämatologisch-onkologische Gemeinschaftspraxis	Münster	Nordrhein-Westfalen
Germany	Praxis für Onkologie u. Hämatologie	Neuss	Nordrhein-Westfalen
Germany	Onkologie Ravensburg	Ravensburg	Baden-Württemberg
Germany	Schwerpunktpraxis Hämatologie / Onkologie	Stade	Niedersachsen

Sponsors (5)

Lead Sponsor	Collaborator
Sponsor GmbH	Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, GlaxoSmithKline, iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4 months	Yes
Secondary	Overall response Rate	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.	12 months	No
Secondary	Progression free survival	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.	12 months	No
Secondary	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.	12 months	No
Secondary	Overall survival (OS)	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.	12 months	No