UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002691 |
|---|---|
| Receipt number | R000003283 |
| Scientific Title | Phase II trial of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with recurrent ovarian cancer |
| Date of disclosure of the study information | 2009/10/29 |
| Last modified on | 2015/07/28 15:48:56 |
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Basic information
Public title
Phase II trial of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with recurrent ovarian cancer
Acronym
Phase II trial of PLD-carboplatin in recurrent ovarian cancer patients
Scientific Title
Phase II trial of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with recurrent ovarian cancer
Scientific Title:Acronym
Phase II trial of PLD-carboplatin in recurrent ovarian cancer patients
Region
| Japan |
Condition
Condition
Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer in late relapse (>6 months) after 1st-line chemotherapy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with patients with ovarian cancer in late relapse (>6 months) after 1st-line chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best overall response (Response rate)
Key secondary outcomes
The incidence of adverse events, overall survival, and 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
Combination chemotherapy consisting of pegylated liposomal doxorubicin (30 mg/m2 iv, day1) and carboplatin (AUC=5 iv, day1) will be administered every 4 weeks. Patients is planned to receive at least 4 cycles of combination treatment and 16 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
| 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 with recurrent disease in late relapse (>6 months) after 1st-line chemotherapy.
4. Patients who have measurable disease by RECIST.
5. Patients who received 1st-line chemotherapy consisting of taxane and carboplatin.
6. ECOG Performance Status: 0-1.
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
Seroum 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 who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation.
8. Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin.
9. Patients who have participated in other clinical trials.
10. Patients who have received prior chemotherapy consisting of doxorubicin.
11. Patients with history of hypersensitivity reactions to the components of pegylated liposomal doxorubicin.
12. Patients who are pregnant, lactating, and have pregnant possibility or intention.
13. Patients who are decided to be ineligible for this trial by the investigators.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saito |
Organization
National Kyushu Cancer Center
Division name
Gynecology
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University, School of Medicine
Division name
Keio Center for Clinical Research
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582
TEL
Homepage URL
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 10 | Month | 29 | 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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003283
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