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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002879
Receipt No. R000003455
Scientific Title Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)
Date of disclosure of the study information 2009/12/12
Last modified on 2019/05/10

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Basic information
Public title Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)
Acronym KCOG G-0901
Scientific Title Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)
Scientific Title:Acronym KCOG G-0901
Region
Japan

Condition
Condition Recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tubal carcinoma, or primary peritoneal carcinoma)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the Maximum Tolerated Dose (MTD) based on Dose Limiting Toxicity (DLT) and define the Recommended Dose (RD) of PLD in combination with TXT at the first course in patients with recurrent or refractory ovarian cancer within 12 months after the first line platinum-based chemotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes To define the RD of PLD in combination with TXT.
Key secondary outcomes To evaluate the best overall response (response rate) and safety of PLD in combination with TXT.

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)+TXT (50-60mg/m2 , day 1)
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 histological or cytological diagnosis of Mullerian carcinoma (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)
2) Patients who are 20 years old or older and younger than 75 years old at the enrollment
3) Patients with recurrence within 12 months after the final course of the first line platinum-based chemotherapy (including recurrence according to marker).
1. Definition of recurrence according to marker: definition of progression according to CA125 (GCIG, 2000)
A) Patients with elevated CA 125 pretreatment and normalization of CA 125
;Doubling in CA 125 from the upper limit of institutional normal range on two occasions
Date of progression: first date of the doubling in CA 125 from the institutional upper normal limit
B) Patients with elevated CA 125 pretreatment, which never normalizes
;Doubling in CA 125 from the nadir on two occasions
Date of progression: first date of the doubling in CA 125 from the nadir
C) Patients with CA 125 in normal range at the pretreatment are as for A
4) Patients who received first line platinum-based chemotherapy
5) ECOG Performance Status(Appendix 1): 0-2
6) Patients who satisfy following organ functions
A) bone marrowfunction
WBC;3000-12000/mm3
ANC;>=1500/mm3
Hb;>=9.0g/dL
Paltelet;>=100000/mm3
B)Liver function
AST,ALT,ALP;2.5 times of institutional
upper normal limit or less
Bilirubin;<1.2mg/dL
C)Renal function
Serum creatinine;1.5 times of institutional upper normal limit or less
D)Cardiac function
LVEF>=50%
ECG;within normal limits or no symptoms without the need of treatment
7) Patients who are expected to survive more than 3 months
8) Patients who have signed informed consent by their own will after they have received a sufficient explanation about the content of the study using the prescribed informed consent form and other explanatory documents
9) Patients who have passed 4 weeks or more since prior treatment
Key exclusion criteria 1) Patients with complications (severe complications or active systemic infection) that may affect the study or assessment of the drugs)
2) Patients with diagnosis of active multiple cancers (synchronous multiple cancers and metachronous multiple cancers within 5 years of disease free interval: exceptions are basal cell carcinoma and squamous cell carcinoma, carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion.)
3) Patients with angina or myocardial infarction within the past 90 days (previous day of the enrollment is defined as day 1 and up to 90 days)
4) Patients who have brain metastasis with symptoms or patients with brain metastasis requiring administration of steroid or antihydropic
5) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation
6) Patients who have received prior chemotherapy consisting of anthracycline (including PLD) or docetaxel
7) Patients with history of hypersensitivity reactions to the components of anthracycline, taxane, or liposomal doxorubicin (MPEG-DSPE, hydrogenated lecithin, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydroxide)
8) Patients who are pregnant, lactating, and have pregnant possibility or intention
9) Patients who are decided to be ineligible for this study by the principal investigator (or subinvestigator)
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Kensuke
Middle name
Last name Hori
Organization kansai rousai hospital
Division name Obstetrics and gynecology
Zip code 6608511
Address Inabasou 3-1-69 , Amagasaki city , Hyogo prefecture , Japan
TEL +81-6416-1221
Email hori-ken@kanrou.net

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name Hori
Organization kansai rousai hospital
Division name Obstetrics and gynecology
Zip code 6608511
Address Inabasou 3-1-69 , Amagasaki city , Hyogo prefecture , Japan
TEL +81-6-6416-1221
Homepage URL
Email hori-ken@kanrou.net

Sponsor
Institute Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Kansai Rosai Hospital
Address 3-1-69, Inabasou, Amagasaki city, Hyogo prefecture, Japan
Tel +81-6-6416-1221
Email hori-kensuke@kansaih.johas.go.jp

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 関西労災病院
大阪大学医学部付属病院
三重大学医学部付属病院
四国がんセンター
久留米大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The administration of 25 mg/m2 of PEG-LD, followed by 50 mg/m2 of docetaxel, on day 1 and every 21 days thereafter in patients with platinum-resistant or partially platinum-sensitive epithelial ovarian cancer appeared to be a well-tolerated regimen with acceptable toxicities. The response rate was 40%, and the disease control rate was 60%. The median overall survival time was 7.4 months (range, 4.5-15.4 months).
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
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 11 Day
Last modified on
2019 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=R000003455

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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