Back to resultsA Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Terminated
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
trastuzumab [Herceptin]
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Median Progression Free Survival (PFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
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.
Percentage of Participants With Overall Tumor Response
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.
Percentage of Participants With Clinical Benefit Response (CBR)
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.
Duration of Response (DR)
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.
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
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.
Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
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.
Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01260194
Brief Title
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
trastuzumab [Herceptin]
Intervention Description
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
Primary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Description
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.
Time Frame
Baseline up to PD or death (maximum up to 22 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Baseline up to death (maximum up to 22 months)
Title
Percentage of Participants With Overall Tumor Response
Description
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.
Time Frame
Baseline up to PD or death (maximum up to 22 months)
Title
Percentage of Participants With Clinical Benefit Response (CBR)
Description
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.
Time Frame
Baseline up to PD or death (maximum up to 22 months)
Title
Duration of Response (DR)
Description
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.
Time Frame
Baseline up to PD or death (maximum up to 22 months)
Title
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
Title
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Description
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.
Time Frame
Baseline up to 6 month after last dose of study drug (maximum up to 22 months)
Title
Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Description
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.
Time Frame
Baseline, thereafter every 12 weeks (maximum up to 22 months)
Title
Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
City
Bangalore
ZIP/Postal Code
560029
Country
India
City
Nagpur
ZIP/Postal Code
440012
Country
India
City
Noida
ZIP/Postal Code
201 301
Country
India
City
Vishakpatnam
ZIP/Postal Code
530002
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
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