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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00706069

Enrollment

Registered

2008-06-27

Start date

2008-06-30

Completion date

2009-07-31

Last updated

2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer, Vinorelbine oral, Capecitabine

Brief summary

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

Detailed description

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)

Interventions

DRUGVinorelbine oral

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

DRUGCapecitabine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Response Rate	Response evaluation at 3rd and 6th cycle by CT's or MRI

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026