UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002879 |
|---|---|
| Receipt number | 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 | 2024/05/16 12:17:59 |
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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
| Obstetrics 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
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
hori-ken@kanrou.net
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
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
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
https://www.kcog.net/%E5%A9%A6%E4%BA%BA%E7%A7%91%E3%82%B0%E3%83%AB%E3%83%BC%E3%83%97/%E9%80%B2%E8%A1
Publication of results
Partially published
Result
URL related to results and publications
https://www.kcog.net/%E5%A9%A6%E4%BA%BA%E7%A7%91%E3%82%B0%E3%83%AB%E3%83%BC%E3%83%97/%E9%80%B2%E8%A1
Number of participants that the trial has enrolled
48
Results
48 patients were enrolled, and 46 were eligible to receive the treatment. The patients median age was 61 years . two cases of carcinosarcoma, and two cases of clear cell carcinoma by histology. Twenty-nine participants received >=6 cycles of chemotherapy. The RR was 71.3% .
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 24 | Day |
Baseline Characteristics
Women aged 20 to 75 years with uterine corpus cancer confirmed histologically, such as endometrioid carcinoma, clearcell carcinoma, squamous cell carcinoma, serous carcinoma, mucinous carcinoma, traditional cell carcinoma, undifferentiated carcinoma, and carcinosarcoma.
Participant flow
46 participants received the dd treatment. Their median age was 61 years. At the time of enrollment, 22 participants had recurrence and the remaining patients had advanced primary uterine corpus cancer. Regarding the histology, there were 10 patients with serous carcinoma, three patients with endometrioid carcinoma G3, two patients with carcinosarcoma, and two patients with clear-cell carcinoma
Adverse events
Twenty-one participants had grade >3 neutropenia and 13 participants had decreased hemoglobin levels. A total of 20 participants experienced some non-hematologic events.
Outcome measures
The primary endpoint was the response rate to the study treatment. and the secondary endpoints were progression-free survival, overall survival, and adverse effects.
Plan to share IPD
Availability of individual data; yes
Available data: Anonymous individual participant data on which the results reported in this paper are based.
Other available data; protocols
IPD sharing Plan description
Data availability period: From 9 months to 36 months after publication of the paper
Who can share: Researchers who have been approved to use the data by an external clinical review board
Purpose: Meta-analysis of individual participant data
How to obtain data: Those who wish to view the data
Send application to: hori-kensuke@kansaih.joha.go.jp with the data viewing consent form and clinical trial review committee approval letter attached.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2009 | Year | 07 | Month | 30 | Day |
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
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003455
