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

Status:	Completed
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	December 2011
End Date:	October 2015

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.

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

We found this trial at

sites

Clinical Trial Facility in New York New York

New York, New York 10032

from

New York, NY