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

NCT01238029 | Terminated Phase 1 DMC

• 1 other identifier: 0907-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

Dose finding study; Combination

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall response Rate

  12 months

• Progression free survival

  12 months

• Time to treatment failure (TTF)

  12 months

• Overall survival (OS)

  12 months

Study Arms (1)

Capecitabine, Lapatinib, Vinorelbine

EXPERIMENTAL

Drug: Lapatinib and Capecitabine and Vinorelbine

Interventions

Lapatinib and Capecitabine and Vinorelbine DRUG

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

Also known as: Xeloda, Tyverb, Navirel

Capecitabine, Lapatinib, Vinorelbine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sponsor GmbH: lead
• iOMEDICO AG: collaborator
• Arbeitsgemeinschaft fur Internistische Onkologie: collaborator
• Arbeitskreis Klinische Studien: collaborator
• GlaxoSmithKline: collaborator

Study Sites (11)

Onkologie Ravensburg

Ravensburg, Baden-Wurttemberg, 88214, Germany

Location

Praxisgemeinschaft Dres. Siehl und Söling

Kassel, Hesse, 34117, Germany

Location

Onkologische Schwerpunktpraxis

Goslar, Lower Saxony, 38642, Germany

Location

Onkologische Schwerpunktpraxis Leer Emden

Leer, Lower Saxony, 26789, Germany

Location

Schwerpunktpraxis Hämatologie / Onkologie

Stade, Lower Saxony, 21680, Germany

Location

Onkodok (Dr. Rösel und Dr. Depenbusch)

Gütersloh, North Rhine-Westphalia, 33332, Germany

Location

Praxis für Hämatologie und Onkologie

Mülheim, North Rhine-Westphalia, 45468, Germany

Location

Hämatologisch-onkologische Gemeinschaftspraxis

Münster, North Rhine-Westphalia, 48149, Germany

Location

Praxis für Onkologie u. Hämatologie

Neuss, North Rhine-Westphalia, 41462, Germany

Location

Onkologische Gemeinschaftspraxis Dörfel/Göhler

Dresden, Saxony, 01127, Germany

Location

Onkologische Schwerpunktpraxis

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib; Capecitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Ulrike Soeling, MD

  Goethestr. 47, 34119 , Kassel, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 10, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

DE (11)