Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

NCT00431106 | Completed Phase 3

• 1 other identifier: CT/02.11
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy; Vinorelbine; Gemcitabine; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression between the two treatment arms

  1 year

Secondary Outcomes (1)

• Overall survival

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Vinorelbine/Gemcitabine (VG)

Drug: Gemcitabine; Drug: Vinorelbine

2

ACTIVE COMPARATOR

Capecitabine (Cap)

Drug: Capecitabine

Interventions

Gemcitabine DRUG

Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles

Also known as: Gemzar

1

Capecitabine DRUG

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

Also known as: Xeloda

2

Vinorelbine DRUG

Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles

Also known as: Navelbine

1

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dept. of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Capecitabine; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: April 1, 2002
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

GR (10)