Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

November 3, 2008 updated by: American University of Beirut Medical Center

A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Study Objective :

To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer

Study Overview

Status

Terminated

Conditions

Breast Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Lebanon
- - Beirut, Lebanon
    - AmericanUBMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Metastatic, histologically or cytologically proven breast cancer.
At least one bi-dimensionally measurable lesion.
Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes.
Treatment as adjuvant is allowed.
World Health Organization-ECOG performance status 0-2.
Adequate renal function (Creatinine <= 1.4 or Creatinine clearance >= 30 ml/min)
Adequate hepatic function (Liver Function Tests not more than 3 times the normal values)
Adequate bone marrow reserve is required (Neutrophils (PMN) >= 2000/mm2 and Platelets >= 100,000/mm2)
Patient who will receive Herceptin should have an over-expression of HER2-neu.

Exclusion Criteria:

Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one).
Pregnant or breast-feeding.
History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma).
Receiving or had received, any treatment with experimental drugs.
Had known brain or leptomeningeal involvement.
Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %.
The presence of bone as a sole site of metastasis.
Radiation therapy to all areas of measurable disease less than four weeks before treatment.
Creatinine two times above the normal range
Hypercalcemia
Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion.
Concomitant steroid intake for > 4 weeks
Bilirubin two times above the normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall response rate Time Frame: During the Study Conduct	During the Study Conduct
time to progression (TTP). Time Frame: during the study conduct	during the study conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
survival Time Frame: During the study conduct	During the study conduct
tolerance Time Frame: During the study conduct	During the study conduct
toxicity. Time Frame: During the study conduct	During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 23, 2006

First Submitted That Met QC Criteria