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Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03766607
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hwan Jung Yun, Korean South West Oncology Group

Brief Summary:
The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Trastuzumab Drug: Ramucirumab Drug: Paclitaxel Phase 2

Detailed Description:

Approximately 15% of patients with advanced gastric cancer have HER2 overexpression and the combined use of trastuzumab and other cytotoxic chemotherapeutic agents, such as 5-FU and cisplatin, in these patients is associated with a significantly improved survival rate compared with cytotoxic chemotherapy alone. So, the combination of trastuzumab and chemotherapy is currently being used as a standard treatment in HER2 positive advanced gastric or gastroesophageal adenocarcinoma. However, after failing first line treatment with such regimen, second line treatment is determined regardless of HER2 status, and the most preferred treatment is ramucirumab and paclitaxel combination chemotherapy.

Recently, the use of trastuzumab in combination with other cytotoxic chemotherapeutic agents has been reported to be superior to the use of cytotoxic chemotherapy alone in the treatment of patients with HER2 positive metastatic breast cancer. On the basis of several guidelines, it is recommended to extend the use of trastuzumab after disease progression. In addition, in some retrospective studies of metastatic gastric cancer, it has been reported that treatment with trastuzumab in combination with second line chemotherapy followed by first line chemotherapy including trastuzumab is beneficial and it is worthwhile to be tested in the prospective study. Furthermore, data on the safety and efficacy of cross-administration of trastuzumab biosimilar have not been available yet.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Trastuzumab with Ramucirumab and Paclitaxel
Single arm study of trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) every 21 days + ramucirumab (8 mg/kg) on days 1 & 15 every 28 days + paclitaxel (80 mg/m2) on days 1, 8, and 15 every 28 days
Drug: Trastuzumab
Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days

Drug: Ramucirumab
Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days

Drug: Paclitaxel
Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days




Primary Outcome Measures :
  1. Progression free survival, PFS [ Time Frame: up to 12 months ]
    as measured from the start of the treatment to the date of either documentation of disease progression or death


Secondary Outcome Measures :
  1. Objective response rate, ORR [ Time Frame: up to 6 months ]
    defined as the proportion of subjects who have a best overall response of complete response or partial response as assessed by RECIST 1.1

  2. Overall survival, OS [ Time Frame: up to 12 months ]
    defined as the time from the date of randomization until the date of death from any cause

  3. Adverse event [ Time Frame: up to 12 months ]
    as measured by NCI-CTCAE v5.0



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over 19 years old
  2. Histologically confirmed HER2 overexpressing gastric cancer (HER2 overexpression is defined as IHC 3+ or FISH +)
  3. Metastatic gastric cancer
  4. Progressive disease has been confirmed after first line treatment including trastuzumab (If the recurrence occurred within 6 months after the completion of postoperative adjuvant therapy, it can be considered as first line treatment.)
  5. At least one measurable or evaluable lesion according to RECIST ver 1.1
  6. ECOG performance status 0 or 1
  7. Appropriate major organ function as defined below, A. Absolute neutrophil count (ANC) ≥ 1,500/mm3 B. Platelet ≥ 100,000/mm3 C. Hemoglobin > 8.0 g/dL D. Total bilirubin ≤ 1.5 x ULN E. AST and ALT < 3 x ULN (if there is a live metastasis, AST and ALT ≤ 5 x ULN) F. Serum creatinine ≤ 1.5x ULN or CCr > 50 mL/min
  8. Life expectancy is more than 12 weeks
  9. Echocardiography at the time of enrollment showed an ejection fraction ≥ 50%
  10. Previous adverse events of chemotherapy or radiotherapy has been resolved to less than grade 1 toxicity (exception: Alopecia, stable peripheral neuropathy, and manageable electrolyte imbalance by replacement therapy are acceptable if they are resolved to less than grade 2)
  11. If the urine pregnancy test or serum beta-hCG result is negative in child bearing women
  12. If the subject have signed the informed consent form approved by the IRB

Exclusion Criteria:

  1. Symptomatic or unstable CNS metastasis (exception: appropriately treated brain metastasis without progression of more than 4 weeks after previous CT or MRI, and no steroid treatment for symptom relief is necessary)
  2. Active virus, bacteria, or fungal infection (exception: HBV DNA titer is in the normal range for chronic hepatitis B carriers)
  3. If previous chemotherapy or radiotherapy was applied within 3 weeks before the administration of study drug
  4. If the subject has received major surgery within 4 weeks and the recovery is not complete before the administration of study drug
  5. If there is a history of other malignancies within 3 years (exception: cervical intraepithelial cancer, well differentiated thyroid cancer, or skin cancer has been treated completely)
  6. QTc interval > 480 msec, long or short QT syndrome, or Burgada syndrome. In addition, known prolongation of QTc interval or Torsade de Pointes
  7. If there is a significant history of cardiovascular disease within 6 months, such as, myocardial infarction, unstable angina, significant cardiac arrhythmia, and uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg), congestive heart failure (NYHA class III-IV), pericardial effusion or pericardial tamponade, cardiomyopathy, cerebrovascular disease including transient ischemic stroke, and symptomatic pulmonary embolism.
  8. History of symptomatic interstitial pneumonia
  9. History of other psychiatric problems, abnormalities of laboratory test which have potential effects on administration of study drugs or participation on the study, or if the subject is inappropriate to be participated according to the investigator's decision (refusal to request and instruction, incooperative attitudes, etc.)

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): NCT03766607


Contacts
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Contact: Eun-Kee Song, M.D. 82-63-250-1245 eksong@jbnu.ac.kr

Locations
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Korea, Republic of
Chonbuk National University Hospital Not yet recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Eun-Kee Song, M.D., Ph.D.    +82-63-250-1245    eksong@jbnu.ac.kr   
Principal Investigator: Eun-Kee Song         
Sponsors and Collaborators
Korean South West Oncology Group
Investigators
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Principal Investigator: Eun-Kee Song Korean Southwest Oncology Group

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Responsible Party: Hwan Jung Yun, Clinical Professor, Korean South West Oncology Group
ClinicalTrials.gov Identifier: NCT03766607     History of Changes
Other Study ID Numbers: KSWOG 1018
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: after discussion

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

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological