NCT00706069

Brief Summary

This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

June 25, 2008

Last Update Submit

December 14, 2009

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast CancerVinorelbine oralCapecitabine

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination

    Toxicity assessment at 1st cycle

  • Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.

    Toxicity assessment at 1st cycle

Secondary Outcomes (1)

  • Response Rate

    Response evaluation at 3rd and 6th cycle by CT's or MRI

Study Arms (1)

1

EXPERIMENTAL

Vinorelbine oral plus Capecitabine

Drug: Vinorelbine oralDrug: Capecitabine

Interventions

Vinorelbine oralDRUG

Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday

Also known as: Navelbine oral
1
CapecitabineDRUG

Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days

Also known as: Xeloda
1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed metastatic breast cancer
  • Age 18-75 years
  • Bidimensionally measurable or evaluable disease
  • Performance status (PS) 0-2 (ECOG)
  • Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment
  • Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the UNL in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  • At least three weeks from completion of irradiation
  • Life expectancy ≥ 12 weeks
  • Patients able to take oral medication
  • written informed consent

You may not qualify if:

  • Active infection
  • Brain metastases
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • Malnutrition (loss of ≥ 20% of the original body weight)
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

VinorelbineCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Nikos Malamos, MD

    "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

GR(4)