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Herzuma-capecitabine/Cisplatin for Gastric Cancer (HERZUMA-GC)

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ClinicalTrials.gov Identifier: NCT03588533
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Celltrion
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

Brief Summary:

Stomach cancer is the fifth largest cancer in the world. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months.

According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor 2 (HER-2). And Using of Trastuzumab reported better results.Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody.

In this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.


Condition or disease Intervention/treatment Phase
HER-2 Positive Gastric Cancer Metastatic Cancer Drug: Trastuzumab Drug: Capecitabine Drug: Cisplatin Phase 2

Detailed Description:

Stomach cancer is the fifth largest cancer in the world, with an estimated 723,000 patients each year, and cancer-related deaths being the third leading cause. In contrast to the decline in the West, the Far East Asia, including South Korea, showed a high prevalence of cancer. In 2014, 29,854 new cases of cancer were reported in Korea. This is the second most important cancer in terms of incidence and the third in cancer related mortality.

The 5 year survival rate has increased to 74 % due to increased early detection of stomach cancer, but in the case of metastatic stomach cancer, the rate of gastric cancer is about one-third of the total number of stomach cancer cases, resulting in poor outcomes. Treatment is 5-fluorouracil, Oxaliplatin, Irinotecan, Epirubicin , Docetaxel, etc. based on platinum or non-platinum. Despite many combinations of studies, metastatic stomach cancer shows a median survival period of 10 to 12 months..

According to a report in Korea in 2010, 17 % of cancer patients had over-expression of human epidemiology growth factor receptor-2(HER-2). And Using of Trastuzumab reported better results in progression free survival (18.6 months vs. 17.1 months) and total overall survival (13.8 months vs. 11.1 months) (hazard ratio 0.74 ; 95 % confidential interval(CI) 0.60-0.91 ; p=0.0046) Trastuzumab was first used for HER-2 and breast cancer, and in three weeks of treatment, it is recommended to perform an induction phase of 8 mg/kg of 90 min and then a maintenance phase of 6mg/kg of 30min to 60min infusion. However, clinical research and data analysis are required because of concerns of toxic expression due to short-term injection. The phase I study of the maintenance 30 minutes toxicity was performed in breast cancer, and there was little difference from 60 minutes of injection in a 250ml or 100ml solution or new toxic event.

Herzuma® is the Trastuzumab biosimilar (Biosimilar) cloned antibody. In the phase I pharmacodynamics study, same the results with trastuzumab were reported. Biosimilar use was approved based on the results of a phase III clinical study on breast cancer. A double-blind, random assignment test was conducted on 549 HER-2 positive breast cancer patients comparing the validity and stability of Trastuzumab. The primary goal was to achieve a postoperative pathologic complete remission in 46.8 % of Herzuma® compared to 50.4% of trastuzumab. In addition, the secondary goal of "overall response rate " and "pharmacodynamics" showed the same results as the Trastuzumab control group.

Biosimilar Herzuma® licensed through breast cancer study also can be used in HER-2 overexpressed stomach cancer. However, there has not been a study on the effects and side effects of the drug.

So in this study, the investigators want to prospectively analyze the effects and side effects of Herzuma® in gastric or gastroesophageal adenocarcinoma.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description:
  • Herzuma 8mg/kg loading over 90min (1st cycle)
  • Herzuma 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks
  • Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
  • Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients.
Actual Study Start Date : June 10, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Herzuma-capecitabine/cisplatin(XP)
  • Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
  • Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks
  • Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
  • Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks
Drug: Trastuzumab
  • Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
  • Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks
Other Name: Herzuma

Drug: Capecitabine
- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
Other Name: Xeloda

Drug: Cisplatin
- Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks




Primary Outcome Measures :
  1. Adverse event [ Time Frame: up to 12 months ]
    Adverse event related with Herzuma


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 6 months ]
    complete response+partial response by RECIST

  2. Progression free survivals (PFS) [ Time Frame: up to 12 months ]
    PFS

  3. All adverse events [ Time Frame: up to 12 months ]
    All adverse events during treatment

  4. Overall survivals (OS) [ Time Frame: up to 12 months ]
    OS



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gastric or gastroesophageal junction adenocarcinoma
  2. HER-2 immuno-histochemical (IHC) (3 +) stain or her-2 silver in situ hybridization(SISH)/fluorescence in situ hybridization(FISH) (+)
  3. Herzuma® -capecitabine/cisplatin combination regimen is planned as a first line treatment

Exclusion Criteria:

  1. Other type of cancer of Gastric or gastroesophageal junction adenocarcinoma (e.g., lymphoma, sarcoma)
  2. HER-2 (0/1+) in IHC or her-2 SISH/FISH (-).
  3. Patients who previously performed stomach cancer treatment as a palliative setting.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588533


Contacts
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Contact: Sung Yong Oh, MD +82512402808 drosy@dau.ac.kr
Contact: Enhee Choi, RN +82512405044 dongahicrc8@naver.com

Locations
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Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Contact: Sung Yong Oh, MD    +82512402808    drosy@dau.ac.kr   
Contact: Enhee Choi, RN    +82512405044    dongahicrc8@naver.com   
Sponsors and Collaborators
Sung Yong Oh
Celltrion
Investigators
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Principal Investigator: Sung Yong Oh, MD Dong-A University Hospital

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Responsible Party: Sung Yong Oh, Pricipal Investigator, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT03588533     History of Changes
Other Study ID Numbers: DAUHIRB-18-121
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung Yong Oh, Dong-A University Hospital:
HER-2 Positive
Gastric or gastroesophageal adenocarcinoma
Herzuma

Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Cisplatin
Capecitabine
Trastuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological