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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 (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724386
First received: July 25, 2008
Last updated: March 6, 2014
Last verified: March 2014

July 25, 2008
March 6, 2014
June 1999
October 2005   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00724386 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
November 2012
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00724386
UCIRB 9849
No
University of Chicago
University of Chicago
Amgen
Not Provided
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP