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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- Written informed consent before any study-related activities are carried out

- Age greater than or equal to (>=) 18 years

- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
(Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to
Siewert classification)

- Archived tumor material sample for at least subsequent standardized Epidermal Growth
Factor Receptor (EGFR) expression assessment

- Unresectable advanced (M0) or unresectable metastatic (M1) disease

- At least one radiographically documented measurable lesion in a previously
non-irradiated area according to response evaluation criteria in solid tumors
(RECIST). The primary tumor site is to be considered as a non-measurable lesion only

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Estimated life expectancy greater than (>) 12 weeks

- Medically accepted contraception (if the risk of conception exists)

- Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is
based on the Cockcroft-Gault formula for creatinine clearance

- Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of
normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN

- Bilirubin =< 3 * ULN

- Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter

- Platelets >= 100 * 10^9 per liter

- Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)

- Sodium and potassium within normal limits or =< 10 percent 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/m^2
cisplatin has been administered

- Prior treatment with an antibody or molecule targeting EGFR and/or Vascular
Endothelial Growth Factor Receptor (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 within 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)

- Clinically relevant coronary artery disease (New York Heart Association [NYHA]
functional angina classification III/IV), congestive heart failure (NYHA III/IV),
clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months
before study Screening, or high risk of uncontrolled arrhythmia

- Active Hepatitis B or C

- Chronic diarrhea or short bowel syndrome

- Presence of any contra-indication to treatment with cetuximab, capecitabine and
cisplatin including:

- Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to
any of the excipients of these drugs

- Known dihydropyrimidine dehydrogenase (DPD) deficiency

- Hereditary problems of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption

- Current treatment with sorivudine or chemically related analogues, such as
brivudine

- Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology
Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE
Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass

- Pregnancy or lactation period

- Concurrent treatment with a non-permitted drug

- Treatment in another clinical study within 30 days prior to study screening

- Previous malignancy other than gastric cancer within 5 years prior to study
screening, except for basal cell cancer of the skin or pre-invasive cancer of the
cervix

- Medical or psychological conditions that would not permit the subject to complete the
study or sign informed consent

- Legal incapacity or limited legal capacity

- Significant disease which, in the Investigator's opinion, would exclude the subject
from the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments

Outcome Description:

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.

Outcome Time Frame:

Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

Safety Issue:

No

Principal Investigator

Florian Lordick, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

EMR 200048-052

NCT ID:

NCT00678535

Start Date:

June 2008

Completion Date:

February 2013

Related Keywords:

  • Gastric Cancer
  • 1st line treatment for Gastric Cancer
  • Cetuximab
  • Capecitabine
  • Xeloda
  • Cisplatin
  • Progression-free survival
  • Adenocarcinoma
  • Stomach Neoplasms

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