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

July 13, 2018 updated by: Sung Yong Oh

Safety and Efficacy Evaluation of Capecitabine, Cisplatin, and Herzuma Combination Chemotherapy for the First Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

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

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Herzuma
Drug: Capecitabine
- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
Other Names:
  • Xeloda
Drug: Cisplatin
- Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: up to 12 months
Adverse event related with Herzuma
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: up to 6 months
complete response+partial response by RECIST
up to 6 months
Progression free survivals (PFS)
Time Frame: up to 12 months
PFS
up to 12 months
All adverse events
Time Frame: up to 12 months
All adverse events during treatment
up to 12 months
Overall survivals (OS)
Time Frame: up to 12 months
OS
up to 12 months

Collaborators and Investigators

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

Sponsor

Sung Yong Oh

Collaborators

Celltrion

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)

June 10, 2018

Primary Completion (ANTICIPATED)

August 31, 2019

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (ACTUAL)

July 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAUHIRB-18-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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