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

NCT ID: NCT04309578

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-12
• Study Completion Date: 2024-12-31

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 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

Conditions

Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Single arm

Group Type: EXPERIMENTAL

Trastuzumab, Capecitabine and Cisplatin

Intervention Type: DRUG

• 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

Interventions

Trastuzumab, Capecitabine and Cisplatin

• 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Diseases measurable according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) using imaging technique (CT or MRI).

3. 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).

4. ECOG Performance status 0, 1 or 2 (see Annex 12.1).

5. Survival for at least 3 months should be possible.

7. Males or females aged 19 years.

8. Patients should sign the informed consent form (ICF).

Exclusion Criteria

1. 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).

2. 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).

3. Patients with active (serious or uncontrolled) gastrointestinal bleeding.

4. Patients with relevant toxicities remaining following previous curative therapy (except for alopecia). For example, neurotoxicity ≥ grade 2 based on NCI-CTCAE version 5.0.

5. 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

6. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.

7. 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.

8. 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.

9. 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.

10. Baseline left ventricular ejection fraction (LVEF) < 50% (measured with echocardiogram or MUGA).

11. Patients with dyspnoea at rest due to advanced tumors or other diseases, or who need an adjuvant oxygen therapy.

12. 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).

13. Patients with Clinically significant hypoacusis

15. Patients with a history of brain metastasis or clinical evidence.

16. Uncontrolled serious systemic intercurrent diseases (e.g., infection or uncontrolled diabetes).

17. Females who are pregnant or are breast-feeding.

18. Fertile males and females who are unwilling to use effective contraceptive methods.

19. Patients who are treated with another investigational product within 4 weeks prior to the initiation of treatment in this clinical study.

20. 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.).

21. 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.

22. Patients known to have HIV infectivity or active infection with HBV or HCV.

23. Patients with hypersensitivity to the study drug.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Min-Hee Ryu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min-Hee Ryu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min-Hee Ryu, MD, Ph.D

Role: CONTACT

miniryu@amc.seoul.kr

+82230105935

Hyung-Don Kim, MD, Ph.D

Role: CONTACT

kimhdmd@amc.seoul.kr

+82230100236

Facility Contacts

Yoon-Koo Kang, MD, PhD

Role: primary

ykkang@amc.seoul.kr

+82-2-3010-3230

Min-Hee Ryu, MD, PhD

Role: backup

miniryu@amc.seoul.kr

+82-2-3010-5935

Other Identifiers

AMC2002

Identifier Type: -

Identifier Source: org_study_id