Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor: University of Chicago
Study ID: NCT00724386
Phase: PHASE1
Status: Completed

Conditions

Breast Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.