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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005926
Receipt No. R000007000
Scientific Title Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer
Date of disclosure of the study information 2011/07/05
Last modified on 2018/02/06

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Basic information
Public title Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer
Acronym Phase I-II study of Irinotecan and Gemcitabine for recurrent ovarian cancer
Scientific Title Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer
Scientific Title:Acronym Phase I-II study of Irinotecan and Gemcitabine for recurrent ovarian cancer
Region
Japan

Condition
Condition taxane/platinum resistant ovarian, fallopian tube and peritoneal cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The Objective is to evaluate the feasibility of combination chemotherapy with Irinotecan and Gemcitabine for recurrent ovarian, fallopian tube or peritoneal cancer and to determine the recommended dose (Phase I). In Phase II study, the objective is to evaluate the response rate of this chemothearpy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Recommended Dose
Response Rate
Key secondary outcomes Safety
Overall Survival
Progression Free Survival

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 A combination chemotherapy with Irinotecan (80-100 mg/m2) and Gemcitabine (800-1000 mg/m2) is administered on days 1 and 8 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
75 years-old >=
Gender Female
Key inclusion criteria 1)Patients with ovarian, fallopian tube or peritoneal cancer whose diagnoses were confirmed by pathologically.
2)
a)PD or SD status less than 6 months after taxane/platinum chemotherapy.
b)Recurrence less than 6 months after taxane/platinum chemotherapy.
3)
a)Prior chemotherapy should be within 2 regimens.
b)Patients who were not administered Irinotecan or Gemcitabine.
c)No chemotherapy within 4 weeks prior to the registration.
4)Patients who have not received radiotherapy.
5)Patients who have measurable disease.
6)Performance Status (ECOG):0-2
7)Patients who are 20 years old or older and younger than 75 years old.
8)Patients who are expected to survive at least 3 months.
9)Patients wh have adequate bone marrow, cardiac, respiratory, hepatic , and renalfunction .
10)Patients who have signed an approved informed consent.
11)Patients who's UGT1A1 genotypes were evaluated.
Key exclusion criteria 1)Patients who have a history of severe hypersensitivity to drug.
2)Patients with interstitial pneumonia.
3)Patients who have mmasive ascites and/or pleural effusion.
4)Patients who have severe infectious diseases.
5)Patients with other malignant disease.
6)Women at pregnant state or possibly pregnant women.
7)Patients with mental diseases.
8)Patients with symptomatic brain metastasis.
9)Patients with severe coronary disease.
10) Patients with uncontrollable diabetic disease.
11)Patients with watery diarrhea.
12)Patients with severe ileus.
13)Patients with intestinal bleeding.
14)Patients with positeve HBs antigen.
15)Patients with severe medical complications.
16)Patients with systematic edema.
17)Patients who are considered inappropriate for this study by the doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Yoshino
Organization Osaka university, faculty of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Email yoshino@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Yoshino
Organization Osaka university, faculty of medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Homepage URL
Email yoshino@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka university, faculty of medicine
Institute
Department

Funding Source
Organization none
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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29080971
Number of participants that the trial has enrolled
Results
PURPOSE: 
To develop a new therapeutic strategy for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers, we evaluated the feasibility and efficacy of irinotecan and gemcitabine combination chemotherapy.
METHODS: 
Patients with taxane/platinum-resistant/refractory cancer received escalating doses of irinotecan and gemcitabine (level 1: 80 and 800 mg/m2, respectively; level 2: 100 and 1000 mg/m2) on days 1 and 8 on a 21-day cycle. Genotyping for UGT1A1*6 and *28 polymorphisms was performed for possible adverse irinotecan sensitivity.
RESULTS: 
A total of 35 patients were enrolled. The recommended dose was defined as 100 mg/m2 irinotecan and 1000 mg/m2 gemcitabine (level 2). The observed common grade 3/4 toxicities were neutropenia (60%), anemia (17.1%), diarrhea (8.6%), thrombocytopenia (5.7%) and nausea (5.7%). Groups homozygous for UGT1A1*6 or *28 were associated with grade 3/4 neutropenia and diarrhea. Objective responses were 20%, including one complete response and six partial responses. In 29 patients treated with the recommended dose, the median progression-free survival and overall survival were 3.8 months (95% CI 2.1-6.0 months) and 17.4 months (95% CI 9.9-21.9 months), respectively, while the 1-year survival rate was 58.6%.
CONCLUSIONS: 
Combination chemotherapy with irinotecan and gemcitabine represents a safe and effective treatment combination for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers.
Results date posted
Results Delayed
Results Delay Reason
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
2011 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2017 Year 06 Month 15 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 05 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007000

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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