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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004602
Receipt No. R000005495
Scientific Title Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial)
Date of disclosure of the study information 2010/11/22
Last modified on 2012/05/10

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Basic information
Public title Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial)
Acronym Phase I trial of CPT-11/PLD for recurrent ovarian cancer
Scientific Title Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial)
Scientific Title:Acronym Phase I trial of CPT-11/PLD for recurrent ovarian cancer
Region
Japan

Condition
Condition Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer recurred during the present chemotherapy or within 6 months after the prior chemotherapy.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the maximum tolerated dose (MTD) and the domestic recommended dose (RD) of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer recurred during the present chemotherapy or within 6 months after the prior chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The maximum tolerated dose of combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin.
Key secondary outcomes The incidence of adverse events and Response Rate.

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 Combination chemotherapy consisting of irinotecan hydrochloride (the following dose level, on day1, 8 and 15) and pegylated liposomal doxorubicin (40 mg/m^2, on day3) will be administered intravenously every 4 weeks.
Dose level of irinotecan
Level-1 40mg/m^2
level 1 50mg/m^2
level 2 60mg/m^2
level 3 70mg/m^2
Patients is planned to receive at least 4 cycles of combination treatment and 12 cycles as the upper limit unless disease progression or unacceptable toxicity is observed.
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
80 years-old >
Gender Female
Key inclusion criteria 1. Patients with a histologic diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
2. Patients who received chemotherapy consisting of platinum.
3. Patients with platinum resistant/refractory recurrent disease.
4. Patients who received chemotherapy within two regimens.
5. ECOG Performance Status: 0-1.
6. Reasonable organ function.
WBC: 3,000-12,000/mm3
ANC: >1,500/mm3
Hb: >10.0g/dL
Platelet: >100,000/mm3
AST, ALT: less than or equal to 2.5x institutional ULN
ALP: less than or equal to 2.5x institutional ULN
Bilirubin: less than or equal to 1.5x institutional ULN
Serum creatinine: less than or equal to 1.5x institutional ULN
No suffering from diarrhea
LVEF: 50% or more
ECG: within normal limits
7. Patients who do not be administered CSF or transfused within two weeks at registration.
8. Patients who have the following periods.
4 weeks or more after the prior surgery
4 weeks or more after the prior radiotherapy
2 weeks or more after the prior chemotherapy, such as hormonal drug, oral antimetabolite, immunetherapy.
6 weeks or more after the prior chemotherapy, such as nitrosourea and mitomycin C.
4 weeks or more after other prior chemotherapy.
9. Patients expected of three months or more survival.
10. Age: 20 years old or older, and under 80 years old.
11. Patients must have signed informed consent.
Key exclusion criteria 1. Patients with severe complications or active infection.
2. Patients with prior diagnosis of malignancy are not eligible. Exceptions are:
-non-melanoma skin cancer, and carcinoma in situ.
-other malignancies curatively treated and > 5 years without evidence of recurrence.
3. Patients with massive pleural effusion and/or ascites.
4. Patients with massive pericardial fluid.
5. Patients with unstable angina or those who have had a myocardial infarction within the past 90 days.
6. Patients who have received prior chemotherapy consisting of irinotecan or anthracyclins.
7. Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic.
8. Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation.
9. Patients who have participated in other clinical trials.
10. Patients with history of hypersensitivity reactions to irinotecan or the components of pegylated liposomal doxorubicin.
11. Patients who are pregnant, lactating, and have pregnant possibility or intention.
12. Patients with diarrhea or watery stool.
13. Patients with bowel paralysis or obstruction.
14. Patients with apparent interstitial pneumonitis or pulmonary fibrosis on chest X-ray.
15. Patients who are receiving Atazanavir.
16. Patients who have genetic polymorphism of homo UGT1A1*6 or *28, or hetero UGT1A1*6 and *28
17. Patients who are decided to be ineligible for this trial by the investigators.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki
Organization School of Medicine, Keio University
Division name Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, 160-8582
TEL 03-3353-1211(ext.62391)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Tsuda
Organization School of Medicine, Keio University
Division name Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, 160-8582
TEL 03-5363-3819
Homepage URL
Email htsud@sc.itc.keio.ac.jp

Sponsor
Institute School of Medicine, Keio University Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor St. Marianna University, School of Medicine
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 慶應義塾大学医学部 産婦人科(東京都)
聖マリアンナ医科大学 産婦人科(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Terminated
Date of protocol fixation
2010 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 22 Day
Last modified on
2012 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005495

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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