- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260194
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
November 1, 2016 updated by: Hoffmann-La Roche
An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.
Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangalore, India, 560029
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Nagpur, India, 440012
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Noida, India, 201 301
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Vishakpatnam, India, 530002
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Delhi
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New Delhi, Delhi, India, 110085
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Karnataka
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Bangalore, Karnataka, India, 560027
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- HER2 positive tumor (primary tumor or metastasis
- ECOG Performance status 0, 1 or 2
- Life expectancy of at least 3 months
Exclusion Criteria:
- Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
- Patients with active (significant or uncontrolled) gastrointestinal bleeding
- Residual relevant toxicity resulting from previous chemotherapy
- Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
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Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Progression Free Survival (PFS)
Time Frame: Baseline up to PD or death (maximum up to 22 months)
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The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first.
PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
The censoring date was the last date of "last tumor measurement," "last date of study drug treatment," or "last follow-up."
The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.
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Baseline up to PD or death (maximum up to 22 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Baseline up to death (maximum up to 22 months)
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OS was defined as the time from the date of enrollment to the date of the death (from any cause).
If no death was observed, censored observations were taken into account in the analysis.
The censoring date was the last date of "last tumor measurement," "last date in drug log," or "last follow-up."
The median overall survival time with 95% CI was estimated using Kaplan Meier method.
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Baseline up to death (maximum up to 22 months)
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Percentage of Participants With Overall Tumor Response
Time Frame: Baseline up to PD or death (maximum up to 22 months)
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Overall tumor response was defined as the occurrence of either a confirmed complete response (CR) or a partial response (PR) as best overall response as determined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1 from confirmed radio-graphic evaluations of target and non-target lesions.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<]10 mm); no new lesions.
PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.
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Baseline up to PD or death (maximum up to 22 months)
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Percentage of Participants With Clinical Benefit Response (CBR)
Time Frame: Baseline up to PD or death (maximum up to 22 months)
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CBR was defined as any response among stable disease (SD) for 6 weeks or longer, CR, or PR as determined by the RECIST v 1.1.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.
PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
SD was defined as not qualifying for CR, PR, or PD.
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Baseline up to PD or death (maximum up to 22 months)
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Duration of Response (DR)
Time Frame: Baseline up to PD or death (maximum up to 22 months)
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DR was based on RECIST criteria v1.1 and was defined as time from date the CR or PR was first recorded to the date on which PD was first noted.
CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions.
PD: at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions and/or appearance of 1 or more new lesions.
For the participants with no documented progression after CR or PR, the censored date (the date of "death," the "last tumor measurement," "last date in drug log," or "last follow-up") was taken into consideration.
The median duration of response with 95% CI was estimated using Kaplan Meier method.
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Baseline up to PD or death (maximum up to 22 months)
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
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An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs included both serious and non-serious AEs.
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Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time Frame: Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
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Lab parameters assessed during the study were serum chemistry, biochemistry - serum electrolytes, hematology, 12 lead electrocardiogram, and urinalysis - protein, glucose, blood and other lab tests.
Laboratory tests were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 3.
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Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
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Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, thereafter every 12 weeks (maximum up to 22 months)
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The LVEF was measured using Multi Gated Acquisition (MUGA) or echocardiography (echocardiography was preferred), using the same technique throughout for consistency in an individual participant.
Baseline LVEF assessments were done within 21 days prior to the start of treatment.
Participants with clinically significant change from baseline (that is, absolute drop in LVEF of >=15%, and drop to a value <50%) have been reported.
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Baseline, thereafter every 12 weeks (maximum up to 22 months)
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Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer
Time Frame: Baseline
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The HER2 status was determination by using immunohistochemistry (IHC) and confirmatory Fluorescent In Situ Hybridization (FISH) techniques.
Only participants with HER2 positivity were allowed to receive study medication.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
December 13, 2010
First Submitted That Met QC Criteria
December 13, 2010
First Posted (ESTIMATE)
December 15, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25477
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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