111
Participants
Start Date
October 23, 2006
Primary Completion Date
October 26, 2018
Study Completion Date
October 26, 2018
Docetaxel, Leucovorin, Fluorouracil, Cisplatin
Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen
"Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17~\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg~Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter."
Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab
"Treatment for Her2 Positive Participants~Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes."
Weill Medical College of Cornell University, New York
Memorial Sloan Kettering Cancer Center 1275 York Avenue, New York
Long Island Jewish Medical Center, New Hyde Park
Queens Cancer Center of Queens Hospital, Jamaica
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack
University of Pittsburgh Cancer Institute, Pittsburgh
Piedmont Hospital Research Institute, Atlanta
Memorial Cancer Institute, Pembroke Pines
University Hospital of Cleveland, Cleveland
Medical College of Wisconsin, Milwaukee
Nebraska Cancer Specialists, Methodist Estabrook Cancer Center, Omaha
City of Hope Cancer Center, Duarte
Memoral Sloan Kettering Cancer Center, Basking Ridge
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital, Sleepy Hollow
Collaborators (2)
Sanofi
INDUSTRY
Roche-Genentech
INDUSTRY
City of Hope National Medical Center
OTHER
Piedmont Hospital Research Institute
UNKNOWN
Medical College of Wisconsin
OTHER
Queens Health Network
OTHER
Weill Medical College of Cornell University
OTHER
Memorial Cancer Institute, Florida
UNKNOWN
University of Pittsburgh
OTHER
Long Island Jewish Medical Center
OTHER
Nebraska Cancer Specialists Methodist Estabrook Cancer Center
OTHER
Memorial Sloan Kettering Cancer Center
OTHER