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