Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

January 6, 2010 updated by: University of New Mexico

INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
Determine the time to relapse after the administration of this regimen.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

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

United States
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico

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:

Patient must have a histological diagnosis of breast cancer with metastasis.
The metastatic disease should be confirmed by biopsy if clinically indicated.
The patient must have measurable or evaluable disease.
Age > 18 years and < 75 years.
The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.
The patient may have received herceptin previously.
The patients must have previously received at least one cycle of chemotherapy.
The patient must have received anthracycline and taxane containing chemotherapy in the past. This may be either in the adjuvant setting or for metastatic disease. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy.
Performance status < 2.
At least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4 associated toxicities at the time of registration. Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present.
Patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease.
The patient should not have uncontrolled CNS disease.
Laboratory parameters: ANC > l500/ l, Platelets >100 000/ l, creatinine < 2.0, bilirubin < 2.0
Informed consent.

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: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study. Time Frame: disease progression or unacceptable toxicities	disease progression or unacceptable toxicities

Collaborators and Investigators

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

Sponsor

University of New Mexico

Investigators

Principal Investigator: Ian Rabinowitz, MD, University of New Mexico

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

May 1, 2000

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria