UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007636 |
|---|---|
| Receipt number | R000009008 |
| Scientific Title | Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2022/09/18 17:39:14 |
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Basic information
Public title
Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
Acronym
HGCSG 1201
Scientific Title
Phase II study of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
Scientific Title:Acronym
HGCSG 1201
Region
| Japan |
Condition
Condition
HER2-positive metastatic or advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and/or safety of trastuzumab with irinotecan in HER2-positive metastatic or advanced gastric cancer patients previously treated with trastuzumab and failed
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression-free survival, six-month survival rate, safety, sub-group analysis by HER2 status(IHC3+, IHC2+/FISH+), sub-group analysis by retesting of HER2 status(retest, no retest), sub-group analysis by HER2 status in HER2 resteted population(changed from most positive and/or positive to positve and/or negative, not changed)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
trastuzumab wiht irinotecan started within 2 weeks of enrollment and repeated until disease progression, unacceptable toxicity, or withdrawal of consent
1. trastzumab given by intravenous infusion in 90 or more minutes at a dose of 8mg/kg on day 1 of the first cycle, followed by 6mg/kg every 3 weeks
2. irinotecan given by intravenous infusion in 90 minutes at a dose of 150mg/m2 every 2 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. histologically, confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach
2. HER2 status scored as 3+ on immunohistochemistry or fluorescence in-situ hybridization positive
3. prior trastuzumab and resistant radiologically confirmed disease progression within 28 days after last dose of 1st line therapy including trastuzumab
4. CT or MRI imaging of disease progression of 1st line therapy by RECIST criteria ver. 1.1 within 28 days of enrollment, and mesurable lesions
5. 14 days or more after last dose of 1st line therapy
6. no prior irinotecan
7. aged 20 or older
8. ECOG performance status 0-2
9. adequate organ function within 14 days of enrollment
10. adequate cardiac function: LVEF 50% or more by echocardiography or MUGA scan within 3 months of enrollment
11. written first-person informed consent
Key exclusion criteria
1. past or current history(within the last 5 years) of malignancies except for the indication under this study and curatively treated:
-Basal and squamous cell carcinoma of the skin
-In-situ carcinoma of the cervix
2. serious and/or uncontrolled complications(infection, pulmonary fibrosis, bowel paralysis, bowel obstrucion, uncontrolled diabetes, hepatic cirrhosis, uncontrolled hypertension, current history(within a year) of myocardial infarction and/or unstable angina)
3. active(obvious or uncontrolled) gastrointestinal hemorrhage
4. cardiac effusion, pleural and/or peritoneal effusion requiring treatment of drainage
5. pregnancy and lactation, and/or without intention of virth control
6. any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Department of Cancer Chemotherapy
Zip code
060-8648
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
ykomatsu@ac.cyberhome.ne.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Department of Clinical Trial Management
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7413
Homepage URL
nanako-ono@huhp.hokudai.ac.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Institute
Department
Personal name
Funding Source
Organization
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院、他、HGCSG参加施設ならびに研究協力施設（約30施設）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
No
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/oncolo/oyab062
Number of participants that the trial has enrolled
16
Results
Sixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual.
The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS)
were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events
were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%).
Results date posted
| 2022 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 18 | Day |
Baseline Characteristics
Number of patients, male 9
Number of patients, female 6
Age Median (range): 65 (42-78) years
Number of prior systemic therapies Median: 1
Performance status: Eastern Cooperative Oncology Group
(ECOG)
0-8
1-7
2-0
3-0
Unknown-0
Other Histology: adenocarcinoma, 15
Extent of disease: metastatic, 13; recurrent, 2
The number of metastatic sites per patient: median 2 (range 1-3)
Metastatic site: lymph node, 11; liver, 10; lung, 3; peritoneum, 2
Previous gastrectomy: 3
Previous adjuvant therapy 2
HER2 status: IHC 2+/FISH positive, 5; IHC 3+, 10
Prior therapy: trastuzumab with capecitabine plus cisplatin, 12;
trastuzumab with S-1 plus cisplatin, 3
Cancer types or histologic subtypes Intestinal, 9; diffuse, 6
Participant flow
Number of patients screened 16
Number of patients enrolled 16
Number of patients evaluable for toxicity 15
Number of patients evaluated for efficacy 15
Adverse events
The most frequently reported grades 3-4 AEs were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%). The median left ventricular
ejection fractions before and after treatment were 66% and 62%, respectively.
Regarding the causes of treatment discontinuation, 12 patients had disease progression, and 3 patients withdrew consent in response to AEs. Specifically, 2
patients withdrew because of grade 3 anorexia and fatigue, and 1 patient withdrew because of grade 2 anorexia and grade 1 alopecia.
Outcome measures
(Median) duration assessments PFS 2.4 months, CI: 0.0-5.2
(Median) duration assessments OS 9.7 months, CI: 8.2-11.2
(Median) duration assessments duration of treatment 1.9 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009008
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