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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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 10, 2011
Last updated: April 2, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Gastric Cancer
Drug: capecitabine
Drug: cisplatin
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall survival in patients with trastuzumab minimum concentrations Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Trastuzumab minimum concentrations (Cmin) on Day 21 of Cycles 1-11 [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Progression-free survival in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]
  • Objective response rate in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1 [ Time Frame: approximately 9 years ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: December 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks
Experimental: B Drug: capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
Drug: cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 10 mg/kg iv every 3 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01450696

  Show 117 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01450696     History of Changes
Other Study ID Numbers: BO27798  2011-001526-19 
Study First Received: October 10, 2011
Last Updated: April 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Stomach Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action processed this record on October 26, 2016