Study With Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00431106

Purpose

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Condition	Intervention	Phase
Breast Cancer	Drug: Gemcitabine Drug: Capecitabine Drug: Vinorelbine	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Time to tumor progression between the two treatment arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	April 2002
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vinorelbine/Gemcitabine (VG)	Drug: Gemcitabine Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles Drug: Vinorelbine Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
2: Active Comparator Capecitabine (Cap)	Drug: Capecitabine Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles

Detailed Description:

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Eligibility

Ages Eligible for Study:	19 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 19-75 years.
Performance status World Health Organization (WHO) 0-2.
Histologically confirmed breast adenocarcinoma.
Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere
- Mitoxantrone or Taxotere + Farmorubicine).
Measurable disease.
No metastatic central nervous system (CNS) disease.
Less than 25% of myeloproductive bone marrow irradiated.
Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
Informed consent.

Exclusion Criteria:

Pregnancy or nursing.
Positive pregnancy test.
Psychiatric illness or social situation that would preclude study compliance.
Other concurrent uncontrolled illness.
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431106

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+30281392857	dorachat@med.uoc.gr

Locations

Greece
"Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Malamos, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology	Recruiting
Piraeus, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
401 Military Hospital of Athens	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalampos Christophillakis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
State General Hospital of Larissa, Dept. of Medical Oncology	Recruiting
Larissa, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Kakolyris, MD
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology	Recruiting
Thessaloniki, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD
Greece, Crete
University Hospital of Crete	Recruiting
Heraklion, Crete, Greece, 71110
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Principal Investigator: Dimitris Mavrudis, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Dimitris Mavrudis, MD

University Hospital of Crete

More Information

No publications provided

Responsible Party:	Hellenic Oncology Research Group ( D. Mavrudis )
Study ID Numbers:	CT/02.11
Study First Received:	February 2, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00431106 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Breast cancer
Chemotherapy
Vinorelbine
Gemcitabine
Capecitabine

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Skin Diseases
Immunologic Factors
Breast Neoplasms
Antiviral Agents
Immunosuppressive Agents

Vinorelbine
Radiation-Sensitizing Agents
Gemcitabine
Taxane
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Capecitabine
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009