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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724386
First received: July 25, 2008
Last updated: July 28, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Paclitaxel
Drug: Vinorelbine
Drug: Filgrastim
Radiation: Radiation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • feasibility of administering study therapy to limit skin toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • dose-limiting toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Bcl-2 detection by immunohistochemistry [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 1999
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    1-hour IV infusion once weekly for 12 to 14 weeks
    Other Name: Taxol
    Drug: Vinorelbine
    escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
    Other Name: Navelbine
    Drug: Filgrastim

    daily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12).

    For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject

    Radiation: Radiation
    Radiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724386

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Amgen
  More Information

No publications provided

Responsible Party: Suzanne Conzen, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00724386     History of Changes
Other Study ID Numbers: UCIRB 9849
Study First Received: July 25, 2008
Last Updated: July 28, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Paclitaxel
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013