Status:
RECRUITING
A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC
Lead Sponsor:
Asan Medical Center
Conditions:
Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 FISH- or 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
- 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 24hr 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 \> 180 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.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04309578
Start Date
March 12 2020
End Date
December 31 2024
Last Update
February 28 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea