Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2017

Conditions
Esophageal Squamous Cell Cancer
Interventions
DRUG

Cisplatin, 5-FU

"Arm A: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.~Chemotherapy will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled."

DRUG

Panitumumab

"Arm B: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.~Panitumumab will be administered on Day 1 of each treatment cycle at a dose of 9 mg/kg prior to administration of chemotherapy.~Each treatment cycle is defined as 21 days. Patients are treated until progression of disease occurs or any other reason for treatment withdrawal is fulfilled."

Trial Locations (1)

55101

Johannes-Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik, Mainz

Sponsors
All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Assign Data Management and Biostatistics GmbH

OTHER

collaborator

Assign Clinical Research GmbH

OTHER

lead

AIO-Studien-gGmbH

OTHER

NCT01627379 - Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer | Biotech Hunter | Biotech Hunter