Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborator:
Amgen
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01351038
First received: May 9, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
KRAS Wild Type Resectable Type II Gastric Adenocarcinoma |
Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Primary Outcome Measures:
- Efficacy [ Designated as safety issue: No ]Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
- Safety [ Designated as safety issue: Yes ]Proportion of patients with grade 4 diarrhea
Secondary Outcome Measures:
- Histopathological response [ Designated as safety issue: No ]rate of complete pathological response
- overall survival after one year
- Progression free survival after one year
- Proportion of patients completing 3 treatment cycles
- SafetyNCI CTCAE v.3
| Estimated Enrollment: | 43 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment
3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1
|
Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab
3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
- T2-4 NX M0 disease
- ECOG performance status 0-1
- adequate hematological status
- adequate renal function
- adequate hepatic function
- adequate metabolic function
Exclusion Criteria:
- pregnant or breast feeding women
- previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- arterial or venous thromboembolism within 6 months before enrollment
- clinically significant cardiovascular disease within 1 year before enrollment
- history of interstitial lung disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351038
Contacts
| Contact: Daniela Wolkersdorfer, Dr. | +43 662 4482 ext 2988 | d.wolkersdorfer@agmt.at |
Locations
| Austria | |
| LKH Feldkirch | Not yet recruiting |
| Feldkirch, Austria, 6807 | |
| Contact: Lang alois.lang@lkhf.at | |
| Principal Investigator: Alois Lang, MD | |
| KH Elisabethinen Linz | Recruiting |
| Linz, Austria, 4010 | |
| Contact: Ziebermayr reinhard.ziebermayer@elisabethinen.or.at | |
| Principal Investigator: Reinhard Ziebermayr, MD | |
| AKh Linz | Recruiting |
| Linz, Austria, 4021 | |
| Contact: Fridrik michael.fridrick@akh.linz.at | |
| Principal Investigator: Michael Fridrik, MD | |
| Universitätsklinik für Innere Medizin III | Recruiting |
| Salzburg, Austria, 5020 | |
| Contact: Greil +43 662 4482 ext 2847 r.greil@salk.at | |
| Principal Investigator: Richard Greil, MD | |
| Klinikum Kreuzschwestern Wels GmbH | Recruiting |
| Wels, Austria, 4600 | |
| Contact: Thaler josef.thaler@klinikum-wels.at | |
| Principal Investigator: Josef Thaler, MD | |
| St. Vinzenz Krankenhaus Betriebs GmbH | Recruiting |
| Zams, Austria, 6511 | |
| Contact: Edward Wöll, Prim. Univ. Doz. Dr. +43 5442 600 ext 7421 e.woell@krankenhaus-zams.at | |
| Principal Investigator: Ewald Wöll, MD | |
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Amgen
More Information
No publications provided
| Responsible Party: | Dr. Daniela Wolkersdorfer, Arbeitsgemeinschaft für medikamentöse Tumortherapie GmbH |
| ClinicalTrials.gov Identifier: | NCT01351038 History of Changes |
| Other Study ID Numbers: | AGMT Gastric-4 |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 9, 2011 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Oxaliplatin Capecitabine Fluorouracil Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013