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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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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

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