Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
• Bevacizumab — DRUG

Study Details

The purpose of this study is to find out what effects (both good and bad) that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved by FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days in a row. Patients then get a break from the drug for seven days. With this schedule and usual dose, some patients on capecitabine have experienced side effects that interfered with their daily comfort.Different doses and schedules of capecitabine have been studied in animal studies and in people with colon cancer. Mathematic modeling has been used to better understand these results.Information from these experiments leads us to ask if 7 days of treatment with capecitabine followed by a 7-day break is both safer and more active against breast cancer. The study you are considering is a first step in this direction and is designed to demonstrate both safety and activity. Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need to grow. Women whose breast cancer spread to other parts of their bodies lived longer without their cancers growing when they were treated with bevacizumab and chemotherapy. Bevacizumab was tested with the 14-day/7-day schedule of capecitabine. These two medicines are safe when given together and seem to work better against breast cancer than capecitabine alone. This study is designed to answer the questions: 1. What are the side effects of bevacizumab and capecitabine when given in this different schedule and how often do they occur? 2. When given in this schedule, does capecitabine with bevacizumab help treat breast cancer that has spread or continues to grow despite being treated by other chemotherapy drugs before?

Key Dates

First listed

May 3, 2007

Start date

Jun 30, 2005

Status verified

Dec 2015

Primary completion

Apr 30, 2011

Completion

Apr 30, 2011

Study Design

Enrollment

62 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1 Capecitabine and Bevacizumab
  The Phase II trial has a Simon mini-max two-stage design. Twenty-seven patients will be enrolled to the first stage of the Phase II trial, with a target accrual of 40 patients. The treatment dose of capecitabine as determined in the Phase I portion of this trial will be administered orally in two divided doses daily on Days 1 through 7 and Days 15 through 21 in a 28 day cycle. Phase II patients will receive bevacizumab 10 mg/kg intravenously every 2 weeks concurrently with oral capecitabine. Patients will be evaluated for toxicity between Days 3 to 5 (complete blood count only), Day 8, Day 15, and Day 22 during cycle #1. Thereafter, toxicity will be assessed on Days 1 and 15. Efficacy will be assessed with every other week physical examination and radiographic scans of measurable disease every 12 weeks.

Primary Outcome Measure

Overall Objective Response [ Time Frame: 2 years ]

Locations (5)

Find similar trials in Basking Ridge, NJ

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