Stomach NeoplasmsPhase 2NEOPECXNCT01234324
ECX + Panitumumab vs. ECX Alone in Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction
A Phase 2 study testing Epirubicin, Cisplatin, Capecitabine, Panitumumab and Epirubicin, Cisplatin, Capecitabine in people with Stomach Neoplasms and Gastroesophageal Junction Neoplasms, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Gastroesophageal Junction Neoplasms
- What is being tested?
- Epirubicin, Cisplatin, Capecitabine, Panitumumab and Epirubicin, Cisplatin, Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Epirubicin, Cisplatin, Capecitabine, Panitumumab, Epirubicin, Cisplatin, Capecitabine
- Keywords
- Stomach Neoplasms, Gastroesophageal Junction Neoplasms, gastric cancer, cancer of the gastroesophageal junction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin, Cisplatin, Capecitabine, PanitumumabDrug
Also called Xeloda®
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.
Epirubicin, Cisplatin, CapecitabineDrug
Also called Vectibix®, Xeloda®
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ECX + Panitumumab | Experimental | Not described Receives: Drug: Epirubicin, Cisplatin, Capecitabine, Panitumumab |
| Arm 2: EXC alone | Active comparator | Not described Receives: Drug: Epirubicin, Cisplatin, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pT3/T4 categories after surgery
Measured: after 9 weeks treatment
Secondary outcomes (1)
Frequencies of pN2/N3 categories after surgery
Measured: After 9 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, WiSP Wissenschaftlicher Service Pharma GmbH
- Responsible party
- Sponsor
- Investigators
- M. Stahl, Prof. Dr. med., Principal investigator, Klinken Essen-Mitte Evang. Huyssens-Stiftung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234324
- Sponsor's protocol ID
- AIO/CAO-STO-0801
- Other IDs
- 2008-007798-18, 2008
- Acronym
- NEOPECX
- Status last verified
- Jan 2018
- First submitted
- 28 Oct 2010
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H. Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer. 2003 Oct 1;98(7):1521-30. doi: 10.1002/cncr.11660.
PubMed 14508841Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PubMed 16822992Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
PubMed 15269313Garcia I, del Casar JM, Corte MD, Allende MT, Garcia-Muniz JL, Vizoso F. Epidermal growth factor receptor and c-erbB-2 contents in unresectable (UICC R1 or R2) gastric cancer. Int J Biol Markers. 2003 Jul-Sep;18(3):200-6. doi: 10.1177/172460080301800308.
PubMed 14535591Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
PubMed 10735013Stahl M, Maderer A, Lordick F, Mihaljevic AL, Kanzler S, Hoehler T, Thuss-Patience P, Monig S, Kunzmann V, Schroll S, Sandermann A, Tannapfel A, Meyer HJ, Schuhmacher C, Wilke H, Moehler M; Arbeitsgemeinschaft Internistische Onkologie (AIO) Oesophageal and Gastric Cancer Working Group and the Chirurgische Arbeitsgemeinschaft Onkologie (CAOGI/DGAV) of the German Cancer Society. Perioperative chemotherapy with or without epidermal growth factor receptor blockade in unselected patients with locally advanced oesophagogastric adenocarcinoma: Randomized phase II study with advanced biomarker program of the German Cancer Society (AIO/CAO STO-0801). Eur J Cancer. 2018 Apr;93:119-126. doi: 10.1016/j.ejca.2018.01.079. Epub 2018 Mar 20.
PubMed 29501977
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01234324
- Acronym / sponsor ID
- NEOPECX / AIO/CAO-STO-0801
- Keywords
- Stomach Neoplasms, Gastroesophageal Junction Neoplasms, gastric cancer, cancer of the gastroesophageal junction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Amgen, WiSP Wissenschaftlicher Service Pharma GmbH
- Study start
- Oct 2010 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ECX + Panitumumab | Experimental | Drug: Epirubicin, Cisplatin, Capecitabine, Panitumumab |
| Arm 2: EXC alone | Active comparator | Drug: Epirubicin, Cisplatin, Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epirubicin, Cisplatin, Capecitabine, PanitumumabAlso: Xeloda®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. | Drug | Arm 1: ECX + Panitumumab |
| Epirubicin, Cisplatin, CapecitabineAlso: Vectibix®, Xeloda®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. | Drug | Arm 2: EXC alone |
Primary outcome
Frequency of pT3/T4 categories after surgery
Time frame: after 9 weeks treatment
1 secondary outcome
Frequencies of pN2/N3 categories after surgery
Time frame: After 9 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 14508841Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H. Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer. 2003 Oct 1;98(7):1521-30. doi: 10.1002/cncr.11660.
- Background: PubMed 16822992Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
- Background: PubMed 15269313Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
- Background: PubMed 14535591Garcia I, del Casar JM, Corte MD, Allende MT, Garcia-Muniz JL, Vizoso F. Epidermal growth factor receptor and c-erbB-2 contents in unresectable (UICC R1 or R2) gastric cancer. Int J Biol Markers. 2003 Jul-Sep;18(3):200-6. doi: 10.1177/172460080301800308.
- Background: PubMed 10735013Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.
- Derived from this study: PubMed 29501977Stahl M, Maderer A, Lordick F, Mihaljevic AL, Kanzler S, Hoehler T, Thuss-Patience P, Monig S, Kunzmann V, Schroll S, Sandermann A, Tannapfel A, Meyer HJ, Schuhmacher C, Wilke H, Moehler M; Arbeitsgemeinschaft Internistische Onkologie (AIO) Oesophageal and Gastric Cancer Working Group and the Chirurgische Arbeitsgemeinschaft Onkologie (CAOGI/DGAV) of the German Cancer Society. Perioperative chemotherapy with or without epidermal growth factor receptor blockade in unselected patients with locally advanced oesophagogastric adenocarcinoma: Randomized phase II study with advanced biomarker program of the German Cancer Society (AIO/CAO STO-0801). Eur J Cancer. 2018 Apr;93:119-126. doi: 10.1016/j.ejca.2018.01.079. Epub 2018 Mar 20.
- Arbeitsgemeinschaft der internistischen OnkologieLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Stahl, Prof. Dr. med. principal investigator
Klinken Essen-Mitte Evang. Huyssens-Stiftung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin, Cisplatin, Capecitabine, Panitumumab and Epirubicin, Cisplatin, Capecitabine in people with Stomach Neoplasms and Gastroesophageal Junction Neoplasms, run by AIO-Studien-gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pT3/T4 categories after surgery (time frame: after 9 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234324, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.