Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706069
• Other study ID #: CT/07.06
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2008
• Last updated: December 14, 2009
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Athens
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination		Toxicity assessment at 1st cycle	Yes
Primary	Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.		Toxicity assessment at 1st cycle	Yes
Secondary	Response Rate		Response evaluation at 3rd and 6th cycle by CT's or MRI	No