A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
18 Years
N/A
Both
Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer
Trial Information
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
Inclusion Criteria:
- Pathologically confirmed unresectable locally advanced or metastatic gastric or
esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within
5 cm of the EGJ are eligible
- ECOG performance status 0 or 1
- Male or female ≥ 18 years of age
Exclusion Criteria:
- Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or
metastatic gastric or esophagogastric adenocarcinoma
- Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant
chemotherapy or chemoradiotherapy.
- Subjects with resectable disease or suitable for definitive chemoradiation
- Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding
jejunostomy
- Tumors of squamous cell histology
- Known central nervous system metastases
- Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment
or randomization
- Serious or non-healing wound
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression free survival (PFS), as measured by RECIST per local review
Outcome Time Frame:
Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Canada: Health Canada
Study ID:
20060317
NCT ID:
NCT00719550
Start Date:
February 2009
Completion Date:
June 2013
Related Keywords:
- Esophagogastric Junction Adenocarcinoma
- Gastric Cancer
- Esophageal Cancer
- Locally Advanced
- Metastatic
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms
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