Clinical trial NCT01461057: A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Official title: An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)
timeFrame: Day 43
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From randomization of first participant to end of study (approximately 6 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute; Oncological Clinic
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 5
country: Czechia
facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
city: Praha 8
country: Czechia
facility: University Hospital Na Bulovce; Institut of Radiation Oncology
city: Brest
country: France
facility: Hopital Morvan
city: Montpellier cedex 5
country: France
facility: CRLCC Val dAurelle Paul Lam
city: Reims
country: France
facility: Hopital Robert Debre; DERMATOLOGIE
city: Berlin
country: Germany
facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
city: Mannheim
country: Germany
facility: Klinikum Mannheim III. Medizinische Klinik
city: Catanzaro
country: Italy
facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella
state: Calabria
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana; Oncologia
state: Toscana
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center; Medical Oncology
city: Maastricht
country: Netherlands
facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: