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A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer

Phase 1
18 Years
75 Years
Not Enrolling
Metastatic Breast Cancer

Thank you

Trial Information

A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer

The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been
studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with
anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).

In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR)
in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe
leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin
Oncol 19: Abstract 420, 2000)

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Toxicity assessment at 1st cycle

Safety Issue:


Principal Investigator

Nikos Malamos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Greece: National Organization of Medicines

Study ID:




Start Date:

June 2008

Completion Date:

July 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • Vinorelbine oral
  • Capecitabine
  • Breast Neoplasms