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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01450696
First received: October 10, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, open-label, multicenter, international phase IIIb study will co mpare 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 rec eived prior treatment for metastatic disease will be randomized to receive Herce ptin intravenously either an 8 mg/kg loading dose followed by 6 mg/kg every 3 we eks 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 cycl es at a dose of 80 mg/m2 on Day 1 of each 3-week cycle. Anticipated time on stud y 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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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 ]

Estimated Enrollment: 400
Study Start Date: December 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

  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 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 ClinicalTrials.gov identifier: NCT01450696

Contacts
Contact: Reference Study ID Number: BO27798 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 111 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: August 26, 2014
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014