Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

October 23, 2006

Primary Completion Date

October 26, 2018

Study Completion Date

October 26, 2018

Conditions
Gastroesophageal Junction AdenocarcinomaGastric Cancer
Interventions
DRUG

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)

DRUG

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."

DRUG

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."

Trial Locations (15)

10021

Weill Medical College of Cornell University, New York

10065

Memorial Sloan Kettering Cancer Center 1275 York Avenue, New York

11040

Long Island Jewish Medical Center, New Hyde Park

11432

Queens Cancer Center of Queens Hospital, Jamaica

11725

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack

15232

University of Pittsburgh Cancer Institute, Pittsburgh

30309

Piedmont Hospital Research Institute, Atlanta

33025

Memorial Cancer Institute, Pembroke Pines

44106

University Hospital of Cleveland, Cleveland

53226

Medical College of Wisconsin, Milwaukee

68114

Nebraska Cancer Specialists, Methodist Estabrook Cancer Center, Omaha

91010

City of Hope Cancer Center, Duarte

Unknown

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

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Roche-Genentech

INDUSTRY

collaborator

City of Hope National Medical Center

OTHER

collaborator

Piedmont Hospital Research Institute

UNKNOWN

collaborator

Medical College of Wisconsin

OTHER

collaborator

Queens Health Network

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Memorial Cancer Institute, Florida

UNKNOWN

collaborator

University of Pittsburgh

OTHER

collaborator

Long Island Jewish Medical Center

OTHER

collaborator

Nebraska Cancer Specialists Methodist Estabrook Cancer Center

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00515411 - Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma | Biotech Hunter | Biotech Hunter