UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer
Title of the study (Brief title)	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	Kiyoshi Yoshino
Organization	Osaka university, faculty of medicine
Division name	Department of Obstetrics and Gynecology
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3351
Email	yoshino@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person	Kiyoshi Yoshino
Organization	Osaka university, faculty of medicine
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29080971
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.
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