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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Amgen
WiSP Wissenschaftlicher Service Pharma GmbH
Information provided by (Responsible Party):
AIO-Studien-gGmbH
ClinicalTrials.gov Identifier:
NCT01234324
First received: October 28, 2010
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms
Gastroesophageal Junction Neoplasms
Drug: Epirubicin, Cisplatin, Capecitabine, Panitumumab
Drug: Epirubicin, Cisplatin, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AIO-Studien-gGmbH:

Primary Outcome Measures:
  • Frequency of pT3/T4 categories after surgery [ Time Frame: after 9 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequencies of pN2/N3 categories after surgery [ Time Frame: After 9 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 171
Study Start Date: October 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vectibix®, Xeloda®

  Eligibility

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

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
  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: NCT01234324

Locations
Germany
AIO-Studien gGmbH
Berlin, Germany, 10623
Sponsors and Collaborators
AIO-Studien-gGmbH
Amgen
WiSP Wissenschaftlicher Service Pharma GmbH
Investigators
Principal Investigator: Hansjochen Wilke, Prof. Dr. med. Klinken Essen-Mitte Evang. Huyssens-Stiftung
  More Information

Additional Information:
Publications:
Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT01234324     History of Changes
Other Study ID Numbers: AIO/CAO-STO-0801, 2008-007798-18
Study First Received: October 28, 2010
Last Updated: April 25, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AIO-Studien-gGmbH:
Stomach Neoplasms
Gastroesophageal Junction Neoplasms
gastric cancer
cancer of the gastroesophageal junction

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Epirubicin
Fluorouracil
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014