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

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 30, 1999

Primary Completion Date

October 31, 2005

Study Completion Date

November 30, 2012

Conditions
Breast Cancer
Interventions
DRUG

Paclitaxel

1-hour IV infusion once weekly for 12 to 14 weeks

DRUG

Vinorelbine

escalating doses administered intravenously over 6-10 minutes for 12-14 weeks

DRUG

Filgrastim

"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

Trial Locations (1)

60637

University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

University of Chicago

OTHER

NCT00724386 - Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer | Biotech Hunter | Biotech Hunter