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

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450696
• Other study ID #: BO27798
• Secondary ID: 2011-001526-19
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2011
• Last updated: April 2, 2016
• Start date: December 2011
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Drug:
• capecitabine
1600 mg/m2 orally daily Days 1-14 of each 3-week cycle, 6 cycles
• cisplatin
80 mg/m2 iv on Day 1 of each 3-week cycle, 6 cycles
• trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks
• trastuzumab [Herceptin]
8 mg/kg iv loading dose, followed by 10 mg/kg iv every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Brazil,  Chile,  China,  Czech Republic,  Germany,  Hungary,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Russian Federation,  Serbia,  South Africa,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		approximately 9 years	No
Secondary	Duration of overall survival in patients with trastuzumab minimum concentrations Cmin <12 mcg/mL on Day 21 of Cycle 1		approximately 9 years	No
Secondary	Trastuzumab minimum concentrations (Cmin) on Day 21 of Cycles 1-11		33 weeks	No
Secondary	Safety: Incidence of adverse events		approximately 9 years	No
Secondary	Progression-free survival in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1		approximately 9 years	No
Secondary	Objective response rate in patients with trastuzumab Cmin <12 mcg/mL on Day 21 of Cycle 1		approximately 9 years	No