Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

Sponsor

Hellenic Oncology Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00706069

Collaborator

University Hospital of Crete (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Vinorelbine oral Drug: Capecitabine	Phase 1

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Vinorelbine oral plus Capecitabine	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

Arm

Intervention/Treatment

Experimental: 1

Vinorelbine oral plus Capecitabine

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis	Greece
2	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens	Greece
3	"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Athens	Greece
4	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Greece