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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 1-hour IV infusion once weekly for 12 to 14 weeks |
| |
| Vinorelbine | Drug | escalating doses administered intravenously over 6-10 minutes for 12-14 weeks |
| |
| Filgrastim | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of administering study therapy to limit skin toxicity | 4 weeks | |
| dose-limiting toxicity | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| response | 14 weeks | |
| time to progression | ||
| overall survival |
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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:
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:
Signed informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| Bcl-2 detection by immunohistochemistry | 14 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077235 | Vinorelbine |
| D000069585 | Filgrastim |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D055585 | Physical Phenomena |
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