Trial Information
Randomized Phase II Open-label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-gastric Adenocarcinoma
Inclusion Criteria:
- Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third
of the esophagus
- metastatic disease
- immunohistological evidence of EGFR expression from archived tissues
- ECOG PS 0-1
- at least 1 measurable lesion (modified WHO criteria)
Exclusion Criteria:
- previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed > 12 months
prior to study treatment
- radiotherapy or major surgery within 4 weeks prior to treatment
- brain metastases
- peripheral neuropathy or ototoxicity >/= Grade 2 (NCICTC V3)
- abnormal ECG
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
various timepoints measured
Safety Issue:
No
Principal Investigator
Professor David Cunningham, MD, FRCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Royal Marsden Hospital, UK
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
EMD 72000-032
NCT ID:
NCT00215644
Start Date:
August 2005
Completion Date:
August 2008
Related Keywords:
- Esophageal Cancer
- Gastric Cancer
- Esophagus
- Gastric
- Adenocarcinoma
- EGFR
- matuzumab
- EMD 72000
- randomized
- Epirubicin
- cisplatin
- capecitabine
- Metastatic Esophago-Gastric cancer
- Adenocarcinoma
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms