Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Approved-not yet active 18 and over Pharmaceutical / Industry EMR 200048-052 NCT00678535

Trial Description

Summary

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

Florian Lordick

Principal Investigator

Isil Montaner		Ph: 34-93-565-5578
		Email: imontaner@merck.es

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00678535
Information obtained from ClinicalTrials.gov on July 16, 2008