UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005525 |
|---|---|
| Receipt number | R000006537 |
| Scientific Title | Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2013/01/31 14:35:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Acronym
Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Scientific Title
Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Scientific Title:Acronym
Phase I Trail of pegylated liposomal doxorubicin (PLD) in combination with Irinotecan (CPT-11) in Patients with Platinum Refractory and Resistant Ovarian cancer
Region
| Japan |
Condition
Condition
Patients with platinum-refractory and resistant ovarian cancer
Classification by specialty
| Obstetrics 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 pegylated liposomal doxorubicin in combination with irinotecan therapy in Patients with platinum-refractory and resistant ovarian cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The maximum tolerated dose of combination chemotherapy consisting of pegylated liposomal doxorubicin in combination with irinotecan
Key secondary outcomes
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
PLD (25-30mg/m2 ,day1)
CPT-11 (50-60mg/m2 , day 1,8)
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 a histologic diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
2) Age: 20 years old or older, and under 75 years old.
3) Patients 1st-line or 2nd-line chemotherapy of platinum is required. Platinum-based regimen and is defined as progressive disease within 12 months of completing the prior therapy.
4) Patients took 3 coourse or more Platinum-based chemotherapy as 1st- or 2nd-line chemotherapy.
5) ECOG Performance Status: 0-1.
6) Patients who have genetic polymorphism of UGT1A1
7) Reasonable organ function.
WBC: 3,000-12,000/mm3
ANC: >1,500/mm3
Hb: >10.0g/dL
Platelet: >75,000/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 institutional ULN
Serum creatinine: less than or equal to 1.5x institutional ULN
LVEF: 50% or more
ECG: within normal limits
8) 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 with brain metastasis who have symptoms or require administration of steroid or antihydropic.
7) Patients with bowel paralysis or obstruction.
8) Patients with diarrhea or watery stool.
9) Patients with apparent interstitial pneumonitis or pulmonary fibrosis
10) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation.
11) Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin.
12) Patients who have participated in other clinical trials.
13) Patients with history of hypersensitivity reactions to doxorubicin or irinotecan or the components of pegylated liposomal doxorubicin.
14) Patients who are pregnant, lactating, and have pregnant possibility or intention.
15) Patients who are decided to be ineligible for this trial by the investigators.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsujioka |
Organization
Fukuoka University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
45-1, 7-chome, Nanakuma, Jyounan-ku, Fukuoka city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuoka University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
TEL
092-801-1011
Homepage URL
Sponsor or person
Institute
Fukuoka University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University, School of Medicine.
Department of Obstetrics and Gynecology
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2011 | Year | 04 | Month | 28 | Day |
Last modified on
| 2013 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006537
