ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction (NEOPECX)

January 19, 2018 updated by: AIO-Studien-gGmbH

An Open Label Randomized Controlled Phase II Trial of Panitumumab in Combination With Epirubicin, Cisplatin and Capecitabine (ECX) Versus ECX Alone in Subjects With Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction.

That panitumumab in combination with Epirubicin, Cisplatin and Capecitabine (ECX) will safely decrease the frequency of pT3/T4 below that of ECX alone in subjects with locally advanced adenocarcinoma of the stomach and gastroesophageal junction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10623
        • AIO-Studien gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Competent to comprehend, sign, and date an IEC-approved informed consent form, written informed consent.
  • Of either gender and aged 18 years or more.
  • Diagnosed with histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction of Type I/II/III according to the classification of Siewert et al, 1996.
  • Stage uT/3 or 4 N0/+ and M0 disease evaluated by endoscopic ultrasound, spiral computed tomography of the chest, abdomen and pelvis and by laparoscopy in uT3/T4 tumors.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Leucocyte count > 3,000/mm3.
  • Platelet count ≥100,000/mm3.
  • Haemoglobin ≥10 g/dl.
  • Serum creatinine ≤ 1.5x of upper limit of normal (ULN).
  • Creatinine clearance > 60 ml/kg/min measured either by 24-h urine sampling or calculated by using the Cockcroft-Gault formula .
  • Aspartate aminotransferase (AST) ≤3 x ULN.
  • Alanine aminotransferase (ALT) ≤3 x ULN.
  • Bilirubin ≤ 1.5 x ULN.
  • Magnesium ≥ lower limit of normal.
  • Calcium ≥ lower limit of normal.
  • Subject is deemed a good candidate for surgery.

Exclusion Criteria:

  • Any metastatic disease.
  • Other malignant tumours less than five years old. Exceptions include basocellular carcinoma, in situ cancer of the cervix of the uterus, or any curatively-treated other malignancies without evidence of disease for more than five years.
  • Significant ascites or pleural effusion.
  • Prior anti-EGFr antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
  • Prior chemotherapy, radiotherapy or antibody therapy for gastric cancer or cancer of the gastro-oesophageal junction.
  • Concomitant therapy with sorivudine or analogue compounds.
  • Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
  • Significant cardiovascular disease including New York Heart Association (NYHA) grade II or greater congestive heart failure, peripheral arterial occlusive disease stage II or greater, symptomatic coronary heart disease, insufficiently treated arterial hypertension, unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
  • History or evidence upon physical examination of CNS disease unless adequately treated, seizure not controlled with standard medical therapy, or history of stroke.
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
  • Pre-existing polyneuropathy grade >1 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), except for loss of tendon reflex as the only symptom.
  • Treatment for systemic infection within 14 days before initiating study treatment.
  • Active inflammatory bowel disease, serious gastric ulceration or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
  • Suspected or known dihydropyrimidine dehydrogenase deficiency (DPD).
  • Thrombosis or severe bleeding within six months prior to entry into the study (except for bleeding of the tumour before its surgical resection), evidence of bleeding diathesis or coagulopathy, or current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants for therapeutic purposes.
  • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus or chronic active hepatitis B infection.
  • Known allergy to the investigational product, to any of its excipients, to monoclonal antibodies, or to any of the components of the chemotherapy regimen.
  • Any co-morbid disease that would increase risk of toxicity.
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
  • Any investigational agent or participation in another clinical trial within 30 days prior to randomisation.
  • Must not have had a major surgical procedure within 28 days of randomisation.
  • Subject who is pregnant or breast feeding.
  • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during the course of the study and for six months after the last study drug administration for women and men. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-child-bearing potential.
  • Subject unwilling or unable to comply with study requirements.
  • Hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: ECX + Panitumumab
Drug: Epirubicin, Cisplatin, Capecitabine, Panitumumab
Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle; Panitumumab: 9 mg/kg bodyweight, administered IV by an infusion pump through a peripheral line or catheter over 60 min +-15 min on day 1 of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
Other Names:
  • Xeloda®
Active Comparator: Arm 2: EXC alone
Drug: Epirubicin, Cisplatin, Capecitabine
Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
Other Names:
  • Vectibix®, Xeloda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of pT3/T4 categories after surgery
Time Frame: after 9 weeks treatment
after 9 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequencies of pN2/N3 categories after surgery
Time Frame: After 9 weeks treatment
After 9 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIO-Studien-gGmbH

Collaborators

Amgen
WiSP Wissenschaftlicher Service Pharma GmbH

Investigators

  • Principal Investigator: M. Stahl, Prof. Dr. med., Klinken Essen-Mitte Evang. Huyssens-Stiftung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO/CAO-STO-0801
  • 2008-007798-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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