Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

March 6, 2014 updated by: University of Chicago

A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • 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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:

    1. patients with locally advanced unresectable stage IIIa or IIIb;
    2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
    3. patients with metastatic disease AND uncontrolled locoregional disease are eligible.
  • Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
  • Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
  • 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
  • Aged 18 years or older
  • CALGB performance status of 0 - 2
  • Life expectance of at least 12 weeks

  • Initial Laboratory Data:

    • ANC Count > 1500/mm3
    • Platelet Count > 100,000/mm3
    • Creatine ≤ 2.0 mg/dl
    • Bilirubin ≤ 1.5 mg/dl
    • ALT (SGPT) ≤ 3 times the upper limit of normal
  • Signed informed consent

Exclusion Criteria:

  • Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
  • Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
  • Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
  • No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment

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
feasibility of administering study therapy to limit skin toxicity
Time Frame: 4 weeks
4 weeks
dose-limiting toxicity
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
time to progression
response
Time Frame: 14 weeks
14 weeks
Bcl-2 detection by immunohistochemistry
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

Amgen

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, 1999

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCIRB 9849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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