A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

NCT ID: NCT01461057

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-06
• Study Completion Date: 2017-10-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pertuzumab 840/420 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.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle

Cisplatin

Intervention Type: DRUG

80 mg/m2 on Day 1 of each cycle

Pertuzumab

Intervention Type: DRUG

loading dose of 840 mg, then 420 mg once every three weeks

Trastuzumab

Intervention Type: DRUG

loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Pertuzumab 840/840 mg

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.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle

Cisplatin

Intervention Type: DRUG

80 mg/m2 on Day 1 of each cycle

Pertuzumab

Intervention Type: DRUG

840 mg once every three weeks

Trastuzumab

Intervention Type: DRUG

loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Interventions

Capecitabine

1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle

Intervention Type: DRUG

Cisplatin

80 mg/m2 on Day 1 of each cycle

Intervention Type: DRUG

Pertuzumab

loading dose of 840 mg, then 420 mg once every three weeks

Intervention Type: DRUG

Pertuzumab

840 mg once every three weeks

Intervention Type: DRUG

Trastuzumab

loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Intervention Type: DRUG

Other Intervention Names

Xeloda; Perjeta; Perjeta; Herceptin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Cliniques Universitaires St-Luc

Brussels, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Masaryk Memorial Cancer Institute; Oncological Clinic

Brno, , Czechia

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

Hradec Králové, , Czechia

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, , Czechia

Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

Prague, , Czechia

University Hospital Na Bulovce; Institut of Radiation Oncology

Prague, , Czechia

Hopital Morvan

Brest, , France

CRLCC Val dAurelle Paul Lam

Montpellier, , 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

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

Frankfurt, , Germany

Klinikum Mannheim III. Medizinische Klinik

Mannheim, , Germany

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

Catanzaro, Calabria, Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milan, Lombardy, Italy

A.O. Universitaria Pisana; Oncologia

Pisa, Tuscany, Italy

Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

Maastricht, , Netherlands

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

Seoul, , South Korea

Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

Seoul, , South Korea

Asan Medical Center; Medical Oncology

Seoul, , South Korea

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Countries

Belgium; Czechia; France; Germany; Italy; Netherlands; South Korea; Spain

Other Identifiers

BP27836

Identifier Type: -

Identifier Source: org_study_id