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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
1-hour IV infusion once weekly for 12 to 14 weeks
escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
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
University of Chicago
Chicago, Illinois, United States
feasibility of administering study therapy to limit skin toxicity
Time frame: 4 weeks
dose-limiting toxicity
Time frame: 4 weeks
response
Time frame: 14 weeks
time to progression
overall survival
Bcl-2 detection by immunohistochemistry
Time frame: 14 weeks
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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