Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

This study has been terminated.
(REAL trial showed a significant difference in OS for reduced EOX and standard EOX)
Sponsor:
Collaborator:
Amgen
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01351038
First received: May 9, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Condition Intervention Phase
KRAS Wild Type
Resectable Type II Gastric Adenocarcinoma
Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]
    Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy

  • Safety [ Designated as safety issue: Yes ]
    Proportion of patients with grade 4 diarrhea


Secondary Outcome Measures:
  • Histopathological response [ Designated as safety issue: No ]
    rate of complete pathological response

  • overall survival after one year
  • Progression free survival after one year
  • Proportion of patients completing 3 treatment cycles
  • Safety
    NCI CTCAE v.3


Estimated Enrollment: 43
Arms Assigned Interventions
Experimental: treatment
3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1
Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
  • T2-4 NX M0 disease
  • ECOG performance status 0-1
  • adequate hematological status
  • adequate renal function
  • adequate hepatic function
  • adequate metabolic function

Exclusion Criteria:

  • pregnant or breast feeding women
  • previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  • arterial or venous thromboembolism within 6 months before enrollment
  • clinically significant cardiovascular disease within 1 year before enrollment
  • history of interstitial lung disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351038

Locations
Austria
LKH Feldkirch
Feldkirch, Austria, 6807
KH Elisabethinen Linz
Linz, Austria, 4010
AKh Linz
Linz, Austria, 4021
Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, 4600
St. Vinzenz Krankenhaus Betriebs GmbH
Zams, Austria, 6511
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Amgen
  More Information

No publications provided

Responsible Party: Dr. Daniela Wolkersdorfer, Arbeitsgemeinschaft für medikamentöse Tumortherapie GmbH
ClinicalTrials.gov Identifier: NCT01351038     History of Changes
Other Study ID Numbers: AGMT Gastric-4
Study First Received: May 9, 2011
Last Updated: June 3, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014