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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008626
Receipt No. R000010136
Scientific Title Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
Date of disclosure of the study information 2012/08/06
Last modified on 2020/01/22

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Basic information
Public title Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
Acronym CPT-11 + Trastuzumab therapy for patients with prior chemotherapy
(HERBIS-5)
Scientific Title Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
Scientific Title:Acronym CPT-11 + Trastuzumab therapy for patients with prior chemotherapy
(HERBIS-5)
Region
Japan

Condition
Condition Advanced Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of CPT-11 + Trastuzumab for HER2-positive advanced gastric cancer patients with prior chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Disease Control Rate
Key secondary outcomes Incidence and grade of AE
Progression-free survival (PFS)
Overall survival (OS)
Response Rate (RR)
Time to treatment failure (TTF)
RR stratified by prior chemotherapy

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 Drug : CPT-11, and trastuzumab
CPT-11 : 150 mg/m2 iv on day 1
Every two weeks
Trastuzumab : 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second courses) every 3 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 unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
2. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive)
3.Patients who provided chemotherapy and confirmed progression by images
4. Patients who have measurable region defined by RECIST version 1.1
5. Age 20 years old or older
6. Performance status (ECOG scale) 0 or 2
7. Patients who can take food oraly
8. Adequate baseline organ and marrow function as defined below;
a. Absolute neutrophil count : >=1,500/ mm3
b. Platelets : >=100,000/mm3
c. Hemoglobin: >=8.0 g/dL
d. AST (SGOT)/ALT (SGPT) : < 150 IU/L
e. Total bilirubin : <1.5 mg/dL
f. Serum creatine : =<2.0 mg/dL
9. Life expectancy of greater than 3 months.
10.LVEF(Left Ventricular Ejection Fraction) is 50% or over
11. Patients should sign a written informed consent
12. Patient with/without prior chemotherapy of Trastuzumab, or Taxan(paclitaxel or docetaxel)
Key exclusion criteria 1. with active double cancer
2. with prior chemotherapy of CPT-11
3. with local/general active infectious disease
4. Serious complication as followings,
a.bleeding on digestive tract
b.Ileus
c.intestinal paralysis
d. Interstitial pneumonia
e. Pulmonary fibrosis
f. ischemic heart disease or cardiac dysrhythmia requiring treatment
g. Heart failure
h. Renal failure
i. Hepatic cirrhosis
j. glaucoma
k. Uncontrolled diabetes mellitus
5. with uncontrollable diarrhea
6. with a history of severe allergy
7. with a middle or large volume of ascites and/or pleural fluid
8. with a continuous administration of steroids
9. with a difficulty on registration to
This study due to psychological disease
10. with a central nerve metastasis
11. With administration of atazanabil
12. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant.
13. Patients have Active hepatitis type B and/or hepatitis C.
14. Any patients judged by the investigator to be
unfit to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka University Graduate School of Medicine
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-2641
Email dsakai@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka University Graduate School of Medicine
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-2641
Homepage URL
Email dsakai@cfs.med.osaka-u.ac.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪府急性期総合医療センター(大阪府)、市立堺病院(大阪府)、西宮市立中央病院(兵庫県)、大阪府立成人病センター(大阪府)、大阪医療センター(大阪府)、八尾市立病院(大阪府)、松下記念病院(大阪府)、東大阪市立総合病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 06 Day

Related information
URL releasing protocol https://academic.oup.com/jjco/article/43/8/838/895219
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason manuscript in preparation
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 23 Day
Date of IRB
2012 Year 09 Month 26 Day
Anticipated trial start date
2012 Year 10 Month 12 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 05 Month 25 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 05 Day
Last modified on
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010136

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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