HELOISE Study: A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
Conditions
Gastric Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: capecitabine Type: Drug
Name: cisplatin Type: Drug
Name: trastuzumab [Herceptin] Type: Drug
Name: trastuzumab [Herceptin] Type: Drug
Overall Status
Recruiting
Summary
This randomized, open-label, multicenter, international phase IIIb study will compare the efficacy and safety of two Herceptin (trastuzumab) dosing regimens in combination with cisplatin/capecitabine chemotherapy in patients with metastatic gastric or gastro-esophageal junction adenocarcinoma. Patients who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously either an 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks or an 8 mg/kg loading dose followed by 10 mg/kg every 3 weeks. Capecitabine will be administered for 6 cycles at a dose of 800 mg/m2 orally twice on Days 1-14 of each 3-week cycle, cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m2 on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression occurs.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients, >/= 18 years of age

- 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 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. Metastasis in distant lymph nodes, peritoneal metastasis, malignant pleural effusion, etc. count as 'organs' in this context

- HER2-positive primary or metastatic tumor

- Adequate renal function (Creatinine clearance >/= 45 mL/min)

- Eastern Cooperative Oncology Group (ECOG) performance status 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 (e.g. patients with a jejunostomy probe, gastric or jejunostomy tubes which may impair the ability to administer or absorb capecitabine)

- Current 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 trans-mural myocardial infraction; poorly controlled hypertension; clinically significant valvular heart disease; or high risk uncontrollable arrhythmias

- Baseline LVEF <50%, documented by echocardiography, MUGA scan, or cardiac MRI

- Chronic high-dose corticosteroid therapy

- History or clinical evidence of brain metastases

- Pregnant women

- Active infection with HIV, hepatitis B, hepatitis C, or HIV-positive
Locations
La Jolla, California, United States
Status: Terminated
Los Angeles, California, United States
Status: Terminated
Whittier, California, United States
Status: Completed
Whittier, California, United States
Status: Completed
Goshen, Indiana, United States
Status: Terminated
Wichita, Kansas, United States
Status: Terminated
New York, New York, United States
Status: Recruiting
Portland, Oregon, United States
Status: Terminated
Charleston, South Carolina, United States
Status: Completed
Port Macquarie, New South Wales, Australia
Status: Recruiting
Wahroonga, New South Wales, Australia
Status: Terminated
Woodville South, South Australia, Australia
Status: Terminated
Murdoch, Western Australia, Australia
Status: Recruiting
Banja Luka, Bosnia and Herzegovina
Status: Recruiting
Sarajewo, Bosnia and Herzegovina
Status: Recruiting
Rio de Janeiro, RJ, Brazil
Status: Active, not recruiting
Porto Alegre, RS, Brazil
Status: Recruiting
Barretos, SP, Brazil
Status: Active, not recruiting
Sao Jose do Rio Preto, SP, Brazil
Status: Not yet recruiting
Sao Paulo, SP, Brazil
Status: Active, not recruiting
Sorocaba, SP, Brazil
Status: Recruiting
Santiago, Chile
Status: Terminated
Santiago, Chile
Status: Recruiting
Viña del Mar, Chile
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Terminated
Beijing, China
Status: Recruiting
Changchun, China
Status: Recruiting
Changsha, China
Status: Recruiting
Changzhou, China
Status: Recruiting
Guangzhou, China
Status: Recruiting
Hangzhou, China
Status: Recruiting
Nanjing, China
Status: Active, not recruiting
Shanghai, China
Status: Recruiting
Wuhan, China
Status: Recruiting
Zhengzhou, China
Status: Recruiting
San Jose, Costa Rica
Status: Not yet recruiting
Brno, Czech Republic
Status: Recruiting
Olomouc, Czech Republic
Status: Recruiting
Praha 2, Czech Republic
Status: Active, not recruiting
Praha 8, Czech Republic
Status: Completed
Berlin, Germany
Status: Recruiting
Frankfurt, Germany
Status: Terminated
Mannheim, Germany
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Budapest, Hungary
Status: Terminated
Pecs, Hungary
Status: Terminated
Szolnok, Hungary
Status: Completed
Szombathely, Hungary
Status: Recruiting
Veszprem, Hungary
Status: Terminated
Catanzaro, Calabria, Italy
Status: Terminated
Napoli, Campania, Italy
Status: Recruiting
Bologna, Emilia-Romagna, Italy
Status: Recruiting
Reggio Emilia, Emilia-Romagna, Italy
Status: Terminated
Udine, Friuli-Venezia Giulia, Italy
Status: Recruiting
Milano, Lombardia, Italy
Status: Recruiting
Ancona, Marche, Italy
Status: Terminated
Florence, Toscana, Italy
Status: Recruiting
Pisa, Toscana, Italy
Status: Terminated
Bundang City, Korea, Republic of
Status: Recruiting
Incheon, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Distrito Federal, Mexico
Status: Recruiting
Mexico City, Mexico
Status: Completed
Monterrey, Mexico
Status: Recruiting
Oaxaca, Mexico
Status: Completed
Auckland, New Zealand
Status: Recruiting
Panama, Panama
Status: Terminated
Arequipa, Peru
Status: Recruiting
Arequipa, Peru
Status: Completed
Lima, Peru
Status: Recruiting
Lima, Peru
Status: Not yet recruiting
Lima, Peru
Status: Terminated
Lima, Peru
Status: Recruiting
Trujillo, Peru
Status: Terminated
Manila, Philippines
Status: Terminated
Pasig City, Philippines
Status: Terminated
Krakow, Poland
Status: Terminated
Lublin, Poland
Status: Completed
Warsaw, Poland
Status: Recruiting
Wieliszew, Poland
Status: Recruiting
Porto, Portugal
Status: Completed
Bucharest, Romania
Status: Not yet recruiting
Cluj-Napoca, Romania
Status: Not yet recruiting
Targu Mures, Romania
Status: Not yet recruiting
Ivanovo, Russian Federation
Status: Recruiting
Omsk, Russian Federation
Status: Recruiting
Ryazan, Russian Federation
Status: Recruiting
St Petersburg, Russian Federation
Status: Recruiting
Stavropol, Russian Federation
Status: Recruiting
Tula, Russian Federation
Status: Terminated
Belgrade, Serbia
Status: Terminated
Belgrade, Serbia
Status: Recruiting
Nis, Serbia
Status: Terminated
Sremska Kamenica, Serbia
Status: Recruiting
Bloemfontein, South Africa
Status: Completed
Cape Town, South Africa
Status: Recruiting
Johannesburg, South Africa
Status: Completed
Barcelona, Spain
Status: Completed
Barcelona, Spain
Status: Completed
Madrid, Spain
Status: Recruiting
Adana, Turkey
Status: Recruiting
Gaziantep, Turkey
Status: Completed
Istanbul, Turkey
Status: Completed
Izmir, Turkey
Status: Completed
Izmir, Turkey
Status: Recruiting
Malatya, Turkey
Status: Recruiting
Sıhhiye, ANKARA, Turkey
Status: Recruiting
Cherkassy, Ukraine
Status: Recruiting
Chernivtsi, Ukraine
Status: Recruiting
Dnipropetrovsk, Ukraine
Status: Recruiting
Donetsk, Ukraine
Status: Active, not recruiting
Kiev, Ukraine
Status: Recruiting
Lvov, Ukraine
Status: Recruiting
Denbighshire, United Kingdom
Status: Terminated
Leicester, United Kingdom
Status: Terminated
Southampton, United Kingdom
Status: Terminated
Wolverhampton, United Kingdom
Status: Recruiting
Start Date
December 2011
Completion Date
May 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page