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A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer (HELOISE)

This study has been terminated.
(futility following planned interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450696
First Posted: October 12, 2011
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastric Cancer
Interventions: Drug: Capecitabine
Drug: Cisplatin
Drug: Herceptin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 248 participants (124 participants per arm) were randomized in the study up to data cutoff date of 13 February 2015, and 48 additional participants (24 participants per arm) were randomized between data cutoff date of 13 February 2015 and end of study (25 August 2015) for additional safety data.

Reporting Groups
  Description
Capecitabine + Cisplatin + Herceptin (6 mg/kg) Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Capecitabine + Cisplatin + Herceptin (10 mg/kg) Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).

Participant Flow:   Overall Study
    Capecitabine + Cisplatin + Herceptin (6 mg/kg)   Capecitabine + Cisplatin + Herceptin (10 mg/kg)
STARTED   148   148 
Treated (Safety Population)   147   147 
COMPLETED   0   0 
NOT COMPLETED   148   148 
Never Treated                1                1 
Death                77                84 
Lost to Follow-up                3                3 
Non-Compliance                1                0 
Withdrawal by Subject                13                2 
Study Terminated by Sponsor                53                58 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) population included all participants who were randomized in this study.

Reporting Groups
  Description
Capecitabine + Cisplatin + Herceptin (6 mg/kg) Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Capecitabine + Cisplatin + Herceptin (10 mg/kg) Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Total Total of all reporting groups

Baseline Measures
   Capecitabine + Cisplatin + Herceptin (6 mg/kg)   Capecitabine + Cisplatin + Herceptin (10 mg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   148   296 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.5  (10.6)   62.4  (10.7)   60.0  (10.7) 
Gender 
[Units: Participants]
     
Female   32   37   69 
Male   116   111   227 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Died - FAS   [ Time Frame: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015) ]

2.  Primary:   Overall Survival - FAS   [ Time Frame: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015) ]

3.  Secondary:   Percentage of Participants Who Died - Per Protocol Set (PPS)   [ Time Frame: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015) ]

4.  Secondary:   Overall Survival - PPS   [ Time Frame: From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015) ]

5.  Secondary:   Percentage of Participants With Disease Progression or Death - PPS   [ Time Frame: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015) ]

6.  Secondary:   Progression-Free Survival - PPS   [ Time Frame: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015) ]

7.  Secondary:   Percentage of Participants With Objective Response - PPS   [ Time Frame: From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015) ]

8.  Secondary:   Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS   [ Time Frame: Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days) ]

9.  Secondary:   Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS   [ Time Frame: Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trial was stopped for futility based on pre-planned interim analysis results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01450696     History of Changes
Other Study ID Numbers: BO27798
2011-001526-19 ( EudraCT Number )
First Submitted: October 10, 2011
First Posted: October 12, 2011
Results First Submitted: October 5, 2016
Results First Posted: November 28, 2016
Last Update Posted: November 28, 2016