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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility of administering study therapy to limit skin toxicity

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UCIRB 9849

NCT ID:

NCT00724386

Start Date:

June 1999

Completion Date:

October 2005

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637