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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

296

Study ID:

NCT01450696

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 114 Locations for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

296

Study ID:

NCT01450696

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

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