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

Sponsor

Sponsor GmbH (Other)

Overall Status

Terminated

CT.gov ID

NCT01238029

Collaborator

iOMEDICO AG (Industry), Arbeitsgemeinschaft fur Internistische Onkologie (Other), Arbeitskreis Klinische Studien (Other), GlaxoSmithKline (Industry)

Enrollment

Locations

Arm

Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine [4 months]
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 [12 months]
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Progression free survival [12 months]
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) [12 months]
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Overall survival (OS) [12 months]
Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Onkologie Ravensburg	Ravensburg	Baden-Württemberg	Germany	88214
2	Praxisgemeinschaft Dres. Siehl und Söling	Kassel	Hessen	Germany	34117
3	Onkologische Schwerpunktpraxis	Goslar	Niedersachsen	Germany	38642
4	Onkologische Schwerpunktpraxis Leer Emden	Leer	Niedersachsen	Germany	26789
5	Schwerpunktpraxis Hämatologie / Onkologie	Stade	Niedersachsen	Germany	21680
6	Onkodok (Dr. Rösel und Dr. Depenbusch)	Guetersloh	Nordrhein-Westfalen	Germany	33332
7	Praxis für Hämatologie und Onkologie	Mulheim an der Ruhr	Nordrhein-Westfalen	Germany	45468
8	Hämatologisch-onkologische Gemeinschaftspraxis	Münster	Nordrhein-Westfalen	Germany	48149
9	Praxis für Onkologie u. Hämatologie	Neuss	Nordrhein-Westfalen	Germany	41462
10	Onkologische Gemeinschaftspraxis Dörfel/Göhler	Dresden	Saxony	Germany	01127
11	Onkologische Schwerpunktpraxis	Heidelberg		Germany	69115