A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    28
  • sponsor
    Asan Medical Center
Updated on 1 July 2021

Summary

A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer

Description

3-weekly/ 1cycle treatment

  • Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks
  • Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
  • Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1

Details
Condition Gastric or Gastroesophageal Junction Adenocarcinoma
Treatment Trastuzumab, Capecitabine and Cisplatin
Clinical Study IdentifierNCT04309578
SponsorAsan Medical Center
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with inoperable, locally-advanced or recurrent and/or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are not eligible for curative therapy and are histologically diagnosed
Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI)
Tissue HER2-negative tumors (primary or metastatic tumors) defined as IHC2+ and FISHor IHC 0 or 1+ according to gastric cancer assessment system for HER2 (see Annex 12.5)
ECOG Performance status 0, 1 or 2 (see Annex 12.1)
Survival for at least 3 months should be possible
Appropriate bone marrow, renal, and hepatic functions. General inclusion criteria
Males or females aged 19 years
Patients should sign the informed consent form (ICF)

Exclusion Criteria

Patients who previously received chemotherapy for advanced/metastatic diseases (adjuvant/neoadjuvant chemotherapy, completed at least 6 months prior to enrollment in this clinical study, is permitted, but platinum-based adjuvant/neoadjuvant chemotherapy is not permitted)
Patients with a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome (e.g., patients who underwent partial or total gastric resection can participate in this clinical study, but patients equipped with a jejunostomy tube cannot participate)
Patients with active (serious or uncontrolled) gastrointestinal bleeding
Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity grade 2 based on NCI-CTCAE version 5.0
Patients with a history of other malignant diseases based on the date of complete recovery within 5 years prior to the initiation of treatment in this clinical study (except for in-situ cervical cancer and basal cell carcinoma)
Hematologic, blood chemistry, and organ functions
\. Neutrophil count < 1.5 109/L, or platelet count < 100 109/L
\. Serum bilirubin> 1.5 upper limit of normal (ULN); or AST or ALT > 2.5 ULN
(or > 5 ULN hepatic metastasis patients); or alkaline phosphatase > 2.5 ULN
(or > 5 ULN hepatic metastasis patients, or > 10 ULN hepatic metastasis-free
bone metastasis patients); or, albumin < 2.5 g/dL
\. Creatinine clearance < 60 mL/min. However, creatinine clearance is first
calculated using the Cockroft-Gault formula, and if the value is < 60ml/min, a
hr urine collection test is carried out. Subject enrollment is possible only
when creatinine clearance is 60mL/min
Other investigational product-associated exclusion criteria
\. History of proven congestive heart failure; angina pectoris in need of
medication; evidence of transmural myocardial infarction through
electrocardiogram (ECG); uncontrolled hypertension (systolic blood pressure >
mmHg or diastolic blood pressure > 100 mmHg); clinically significant heart
valve disorders; and high-risk uncontrolled arrhythmia
\. Baseline left ventricular ejection fraction (LVEF) < 50% (measured with
echocardiogram or MUGA)
\. Patients with dyspnoea at rest due to advanced tumors or other diseases
or who need an adjuvant oxygen therapy
\. Patients who are treated with long-term or high-dose corticosteroids
(steroid inhalation or short-term use of oral steroids for vomiting inhibition
and appetite stimulation is permitted)
\. Patients with Clinically significant hypoacusis
\. Patients known to show dihydropyrimidine dehydrogenase (DPD) deficiency
General exclusion criteria
\. Patients with a history of brain metastasis or clinical evidence
\. Uncontrolled serious systemic intercurrent diseases (e.g., infection or
uncontrolled diabetes)
\. Females who are pregnant or are breast-feeding
\. Fertile males and females who are unwilling to use effective
contraceptive methods
\. Patients who are treated with another investigational product within 4
weeks prior to the initiation of treatment in this clinical study
\. Patients receiving radiation therapy within 4 weeks prior to the
initiation of treatment with the study drug (palliative radiation curative
therapy that is partially carried out for bone metastasis. Washout period of 2
weeks is also permitted in patients recovered from all acute toxicities.)
\. Patients who underwent major surgery within 4 weeks prior to the
initiation of treatment with the study drug and have not yet been completely
recovered
\. Patients known to have HIV infectivity or active infection with HBV or
HCV
\. Patients with hypersensitivity to the study drug
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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