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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002691
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Keio University, School of Medicine
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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003283

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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