Esophageal Cancer Clinical Trial
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
Summary
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
Measurable disease according to RECIST Version 1.1 or non-measurable evaluable disease
At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as "organs" in this context
HER2-positive primary or metastatic tumor as assessed by central laboratory
Adequate renal function (creatinine clearance greater than equal to (≥) 45 milliliters per minute [mL/min])
Eastern Cooperative Oncology Group (ECOG) performance status of 2
Exclusion Criteria:
Previous chemotherapy for locally advanced or metastatic disease
Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
Residual relevant toxicity resulting from previous therapy
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (such as jejunostomy probe and gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine
Current (significant or uncontrolled) gastrointestinal bleeding
Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
Baseline left ventricular ejection fraction (LVEF) less than (<) 50%, documented by echocardiography, multiple-gated radionuclide angiography (MUGA) scan, or cardiac magnetic resonance imaging (MRI)
Chronic or high-dose corticosteroid therapy
History or clinical evidence of brain metastases
Pregnant women
Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or HIV-seropositive
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There are 114 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Whittier California, 90603, United States
Whittier California, 90606, United States
Goshen Indiana, 46526, United States
Wichita Kansas, 67214, United States
New York New York, 10065, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29425, United States
Port Macquarie New South Wales, 2444, Australia
Wahroonga New South Wales, 2076, Australia
Woodville South South Australia, 5011, Australia
Murdoch Western Australia, 6150, Australia
Banja Luka , 78000, Bosnia and Herzegovina
Sarajewo , 71000, Bosnia and Herzegovina
Rio de Janeiro RJ, 20560, Brazil
Porto Alegre RS, 90610, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sorocaba SP, 18030, Brazil
Santiago , 75009, Chile
Santiago , 83804, Chile
Viña del Mar , 25206, Chile
Beijing , 10005, China
Beijing , 10007, China
Beijing , 10014, China
Beijing , 10085, China
Changchun , 13001, China
Changsha , 41000, China
Changzhou , 21300, China
Guangzhou , 51006, China
Hangzhou , 31001, China
Nanjing , , China
Shanghai , 20003, China
Wuhan , 43003, China
Zhengzhou , 45000, China
Brno , 656 5, Czech Republic
Olomouc , 775 2, Czech Republic
Praha 2 , 128 0, Czech Republic
Praha 8 , 180 8, Czech Republic
Berlin , 10117, Germany
Frankfurt , 60488, Germany
Mannheim , 68167, Germany
Budapest , 1097, Hungary
Budapest , 1145, Hungary
Pecs , 7623, Hungary
Szolnok , 5004, Hungary
Szombathely , 9700, Hungary
Veszprem , 8200, Hungary
Catanzaro Calabria, 88100, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Reggio Emilia Emilia-Romagna, 42100, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Milano Lombardia, 20133, Italy
Ancona Marche, 60121, Italy
Florence Toscana, 50124, Italy
Pisa Toscana, 56100, Italy
Bundang City , 463-8, Korea, Republic of
Incheon , 405-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 130-8, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Distrito Federal , 14080, Mexico
Mexico City , 06760, Mexico
Monterrey , 64020, Mexico
Oaxaca , 68000, Mexico
Auckland , 1023, New Zealand
Panama , 0834-, Panama
Arequipa , 04001, Peru
Arequipa , 5154, Peru
Lima , 1, Peru
Lima , 34, Peru
Lima , Lima , Peru
Lima , Lima , Peru
Trujillo , 13011, Peru
Manila , 1000, Philippines
Pasig City , 1605, Philippines
Krakow , 31-50, Poland
Lublin , 20-09, Poland
Warsaw , 00-97, Poland
Wieliszew , 05-13, Poland
Porto , 4200-, Portugal
Ivanovo , 15304, Russian Federation
Omsk , 64401, Russian Federation
Ryazan , 39001, Russian Federation
St Petersburg , , Russian Federation
Stavropol , 35504, Russian Federation
Tula , 30005, Russian Federation
Belgrade , 11000, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Bloemfontein , 9300, South Africa
Cape Town , 7506, South Africa
Johannesburg , 2193, South Africa
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Madrid , 28046, Spain
Adana , 01250, Turkey
Gaziantep , 27100, Turkey
Istanbul , 34890, Turkey
Izmir , 35100, Turkey
Izmir , 35340, Turkey
Malatya , 44280, Turkey
Sıhhiye, ANKARA , 06100, Turkey
Cherkassy , 18009, Ukraine
Chernivtsi , 58013, Ukraine
Dnipropetrovsk , 49102, Ukraine
Donetsk , 83092, Ukraine
Kiev , 03115, Ukraine
Lvov , 79031, Ukraine
Denbighshire , LL185, United Kingdom
Leicester , LE1 5, United Kingdom
Southampton , SO16 , United Kingdom
Wolverhampton , WV10 , United Kingdom
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