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 - Full Text View

Purpose

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: trastuzumab [Herceptin] Drug: capecitabine Drug: cisplatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Cisplatin Capecitabine Trastuzumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Overall survival [ Time Frame: approximately 8 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 8 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 8 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 8 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 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2011
Estimated Study Completion Date:	June 2020
Estimated Primary Completion Date:	June 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: trastuzumab [Herceptin] 8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks 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
Experimental: B	Drug: trastuzumab [Herceptin] 8 mg/kg iv loading dose, followed by 10 mg/kg iv every 3 weeks 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients, >/= 18 years of age
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction
Metastatic disease involving at least 2 organs (at least liver or lung or both)
HER2-positive primary or metastatic tumor
Adequate renal function
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
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
Current gastrointestinal bleeding
Other malignancy within the last 5 years, except for carcinoma in situ of the cervix or squamous cell carcinoma of the skin
History of clinically significant cardio-vascular disease or disorder
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450696

Contacts

Contact: Please reference Study ID Number: BO27798 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 110 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01450696 History of Changes
Other Study ID Numbers:	BO27798, 2011-001526-19
Study First Received:	October 10, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Capecitabine

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013