Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGPaclitaxel
1-hour IV infusion once weekly for 12 to 14 weeks
DRUGVinorelbine
escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
DRUGFilgrastim
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
RADIATIONRadiation
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
Sponsors
Amgen
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility of administering study therapy to limit skin toxicity | 4 weeks |
| dose-limiting toxicity | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| response | 14 weeks |
| time to progression | — |
| overall survival | — |
| Bcl-2 detection by immunohistochemistry | 14 weeks |
Countries
United States
Outcome results
None listed