Clinical trial NCT00706069: Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
Official title: A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
Vinorelbine oral
Capecitabine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-06-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
timeFrame: Toxicity assessment at 1st cycle
measure: Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.
timeFrame: Toxicity assessment at 1st cycle
Secondary outcomes:
measure: Response Rate
timeFrame: Response evaluation at 3rd and 6th cycle by CT's or MRI
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
Study officials:
affiliation: "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
name: Nikos Malamos, MD
role: PRINCIPAL_INVESTIGATOR
References: