Trial | NCT00706069  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients
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)
Study Started
Jun 30
2008
Primary Completion
Jul 31
2009
Study Completion
Jul 31
2009
Last Update
Dec 15
2009
Estimate

Drug Vinorelbine oral

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

  • Other names: Navelbine oral

Drug Capecitabine

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

  • Other names: Xeloda

1 Experimental

Vinorelbine oral plus Capecitabine

Criteria 

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 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

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
No Results Posted