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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Vinorelbine oral; Drug: Capecitabine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Collaborators: University Hospital of Crete
• Investigators: Principal Investigator: Nikos Malamos, MD, "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (ESTIMATE): June 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2009
• Last Update Submitted That Met QC Criteria: December 14, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Capecitabine; Metastatic Breast Cancer; Vinorelbine oral
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Capecitabine; Vinorelbine
• Other Study ID Numbers: CT/07.06