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Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-Gastric Cancer (EXPAND)
This study is currently recruiting participants.
Verified by EMD Pharmaceuticals, August 2008
Sponsored by: Merck KGaA
Information provided by: EMD Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00678535
  Purpose

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with XP chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including GEJ adenocarcinoma, in terms of PFS.

Secondary objectives are to assess cetuximab + XP versus XP alone with respect to overall survival, overall tumor response, quality of life and safety.


Condition Intervention Phase
Gastric Cancer
Drug: Cetuximab + Capecitabine and Cisplatin
Drug: Capecitabine and Cisplatin
Phase III

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Cisplatin Capecitabine Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Open-Label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-Line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

Further study details as provided by EMD Pharmaceuticals:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Various Timepoints ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Various Timepoints ] [ Designated as safety issue: No ]
  • Overall Response [ Time Frame: Various Timepoints ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Various Timepoints ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Various Timepoints ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 870
Study Start Date: June 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Experimental drug + chemotherapy approved
Drug: Cetuximab + Capecitabine and Cisplatin
q week + XP q 3 weeks
B: Active Comparator
Chemotherapy approved
Drug: Capecitabine and Cisplatin
q 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent before any study-related activities are carried out
  • Age ≥ 18 years
  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (AEG types I-III according to Siewert classification)
  • Archived tumor material sample for at least subsequent standardized EGFR expression assessment. Investigators must make sure in advance that appropriate archived tumor material is available from a potentially eligible subject, and that a sample can be shipped to a central repository if the subject agrees to participate.
  • Unresectable advanced (M0) or unresectable metastatic (M1) disease
  • At least one radiographically documented measurable lesion in a previously non-irradiated area according to RECIST
  • ECOG performance status 0-1
  • Estimated life expectancy > 12 weeks
  • Medically accepted contraception (if the risk of conception exists)
  • Glomerular filtration rate ≥ 60mL/min
  • ASAT ≤ 2.5 x ULN and ALAT ≤ 2.5 x ULN
  • Bilirubin ≤ 3 x ULN
  • ANC ≥ 1.5 x 10 to the power of 9/L
  • Platelets ≥ 100 x 10 to the power of 9/L
  • Hemoglobin ≥ 10 g/dL (without transfusions)
  • Sodium and potassium within normal limits or ≤ 10% above or below (supplementation permitted)

Exclusion Criteria:

  • Prior chemotherapy - however: Previous (neo-)adjuvant (radio-)chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m2 cisplatin has been administered
  • Prior treatment with an antibody or molecule targeting EGFR- and/or VEGFR-related signaling pathways
  • Brain metastasis and/or leptomeningeal disease (known or suspected)
  • Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug in the 30 days before the start of study treatment
  • Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol except for physiologic replacement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678535

Contacts
Contact: Isil Montaner 34-93-565-5578 imontaner@merck.es

Locations
Austria
Research Site Not yet recruiting
Wien, Austria
Research Site Not yet recruiting
Zams, Austria
Belgium
Research Site Not yet recruiting
Bonheiden, Belgium
Research Site Not yet recruiting
Bruxelles, Belgium
Czech Republic
Research Site Recruiting
Brno, Czech Republic
Research Site Not yet recruiting
Hradec Králové, Czech Republic
Germany
Research Site Not yet recruiting
Berlin, Germany
Research Site Not yet recruiting
Giessen, Germany
Research Site Recruiting
Heidelberg, Germany
Research Site Not yet recruiting
Schäbisch Hall, Germany
Research Site Not yet recruiting
Hamburg, Germany
Research Site Not yet recruiting
München, Germany
Research Site Recruiting
Mainz, Germany
Research Site Not yet recruiting
Weilheim, Germany
Research Site Not yet recruiting
Regensburg, Germany
Research Site Recruiting
Essen, Germany
Research Site Not yet recruiting
Dresden, Germany
Research Site Not yet recruiting
Troisdorf, Germany
Research Site Not yet recruiting
Timisoara, Germany
Hungary
Research Site Recruiting
Tatabanya, Hungary
Research Site Not yet recruiting
Kaposvar, Hungary
Korea, Democratic People's Republic of
Research Site Recruiting
Seoul, Korea, Democratic People's Republic of
Romania
Research Site Not yet recruiting
Cluj-Napoca, Romania
Research Site Not yet recruiting
Bucharest, Romania
Research Site Recruiting
Iasi, Romania
Spain
Research Site Not yet recruiting
Alicante, Spain
Research Site Recruiting
Santander, Spain
Research Site Not yet recruiting
Valencia, Spain
Taiwan
Research Site Not yet recruiting
Taipei, Taiwan
Research Site Not yet recruiting
Tainan, Taiwan
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Florian Lordick, MD, PhD National Center of Tumour Diseases (NCT), University of Heidelberg, Germany
  More Information

Responsible Party: Merck KGaA ( Isil Montaner )
Study ID Numbers: EMR 200048-052
Study First Received: May 13, 2008
Last Updated: August 27, 2008
ClinicalTrials.gov Identifier: NCT00678535  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by EMD Pharmaceuticals:
1st line treatment for Gastric Cancer

Study placed in the following topic categories:
Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms
Cetuximab
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009