A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT01461057
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pertuzumab 840/420 mg Cisplatin 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. Pertuzumab 840/420 mg Capecitabine 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. Pertuzumab 840/420 mg Pertuzumab 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. Pertuzumab 840/420 mg Trastuzumab 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. Pertuzumab 840/840 mg Capecitabine 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. Pertuzumab 840/840 mg Cisplatin 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. Pertuzumab 840/840 mg Pertuzumab 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. Pertuzumab 840/840 mg Trastuzumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) Day 43 Number of Participants With Adverse Events (AEs) From randomization of first participant to end of study (approximately 6 years) An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Fakultni nemocnice Olomouc; Onkologicka klinika
🇨🇿Olomouc, Czechia
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
🇮🇹Milano, Lombardia, Italy
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Masaryk Memorial Cancer Institute; Oncological Clinic
🇨🇿Brno, Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
🇨🇿Hradec Kralove, Czechia
Fakultnà Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
🇨🇿Praha 5, Czechia
University Hospital Na Bulovce; Institut of Radiation Oncology
🇨🇿Praha 8, Czechia
Hopital Morvan
🇫🇷Brest, France
CRLCC Val dAurelle Paul Lam
🇫🇷Montpellier cedex 5, France
Hopital Robert Debre; DERMATOLOGIE
🇫🇷Reims, France
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
🇩🇪Berlin, Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
🇩🇪Braunschweig, Germany
Klinikum Mannheim III. Medizinische Klinik
🇩🇪Mannheim, Germany
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
🇮🇹Catanzaro, Calabria, Italy
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
🇰🇷Seoul, Korea, Republic of
A.O. Universitaria Pisana; Oncologia
🇮🇹Pisa, Toscana, Italy
Asan Medical Center; Medical Oncology
🇰🇷Seoul, Korea, Republic of
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
🇳🇱Maastricht, Netherlands
Hospital del Mar; Servicio de Oncologia
🇪🇸Barcelona, Spain
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
🇰🇷Seoul, Korea, Republic of
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
🇩🇪Frankfurt, Germany
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
🇪🇸Valencia, Spain
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain