A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer (JOSHUA)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult participants, greater than or equal to (>=) 18 of age
- Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1
- HER2-positive tumor
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
Exclusion Criteria:
- Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Active (significant or uncontrolled) gastrointestinal bleeding
- Abnormal laboratory values
Sites / Locations
- Cliniques Universitaires St-Luc
- UZ Leuven Gasthuisberg
- Masaryk Memorial Cancer Institute; Oncological Clinic
- Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
- Fakultni nemocnice Olomouc; Onkologicka klinika
- Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
- University Hospital Na Bulovce; Institut of Radiation Oncology
- Hopital Morvan
- CRLCC Val dAurelle Paul Lam
- Hopital Robert Debre; DERMATOLOGIE
- Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
- Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
- Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
- Klinikum Mannheim III. Medizinische Klinik
- Campus Universitario S.Venuta; Centro Oncologico T.Campanella
- Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
- A.O. Universitaria Pisana; Oncologia
- Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
- Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
- Asan Medical Center; Medical Oncology
- Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
- Hospital del Mar; Servicio de Oncologia
- Hospital Universitario La Paz; Servicio de Oncologia
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pertuzumab 840/420 mg
Pertuzumab 840/840 mg
Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.