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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001713
Receipt No. R000002066
Scientific Title Phase II Trial of Weekly Intravenous Paclitaxel plus Three Weekly Intraperitoneal Carboplatin Administration for Suboptimally Debulked Ovarian and Primary Peritoneal Carcinoma Incorporating Pharmacogenomic Analysis.
Date of disclosure of the study information 2009/02/16
Last modified on 2009/08/17

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Basic information
Public title Phase II Trial of Weekly Intravenous Paclitaxel plus Three Weekly Intraperitoneal Carboplatin Administration for Suboptimally Debulked Ovarian and Primary Peritoneal Carcinoma Incorporating Pharmacogenomic Analysis.
Acronym Phase II Trial of Weekly Paclitaxel plus IP Carboplatin for Ovarian and Peritoneal Cancer
Scientific Title Phase II Trial of Weekly Intravenous Paclitaxel plus Three Weekly Intraperitoneal Carboplatin Administration for Suboptimally Debulked Ovarian and Primary Peritoneal Carcinoma Incorporating Pharmacogenomic Analysis.
Scientific Title:Acronym Phase II Trial of Weekly Paclitaxel plus IP Carboplatin for Ovarian and Peritoneal Cancer
Region
Japan

Condition
Condition Ovarian Cancer, Peritoneal Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy and safety of weekly administration of paclitaxel plus three weekly intraperitoneal administration of carboplatin for suboptimally debulked ovarian and primary peritoneal cancer. Predictive factors for these outcomes will be assessed by pharmacogenomics analysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate (RECIST)
Key secondary outcomes Overall response duration, Complete response duration, Stable duration, Progression-free survival, Overall survival, Toxicity profiles, frequency, grade, timing, Feasibility of genomic predictive factors for response, Feasiblity of genomic predictive factors for progression-free survival, Establishment of new predictive markers,
Pharmacokinetics of serum paclitaxel.

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 Weekly Paclitaxel 80 mg/m2/week plus 3 Weekly Carboplatin AUC6
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

Not applicable
Gender Female
Key inclusion criteria 1) Histologically confirmed epithelial ovarian or primary peritoneal cancer
2) FIGO Stage II, III, and IV
3) Bard IP Port is placed as Implantable Port System
4) Chemotherapy or radiation therapy should not have been given for the current disease.
5) Protocol treatment must be started within 6 weeks after surgery.
6) The patient must have measurable disease (RECIST) after initial debulking surgery.
7) Age 20 years or older
8) ECOG Performance Status 0-2
9) Life expectancy must be 3 months or longer
10) Patient must have appropriate organ function (bone marrow, cardiac, pulmonary, liver, kidney) and the laboratory value within 7 days before the protocol treatment must be
ANC 2,000/mm3 or more
Platelet 100,000/mm3 or more
GOT, GPT x2 institutional ULN or less
(not applicable for patients with liver metastasis)
Serum Total Bilirubin 1.5 mg/dL or less
Serum Creatinine 1.5 mg/dL or less
Preoperative EKG Normal
11) Written informed consent must be obtained for the study including blood or tissue sampling
Key exclusion criteria 1) Patients who did not meet the above mentioned inclusion criteria.
2) Patients who underwent colo-rectal resection at the initial debulking surgery
3) Patients with active double cancer excluding skin cancer except for melanoma
4) Patients with past history of cancer, and who meet following criteria is NOT eligible
Patients who received radiotherapy to the abdomen or pelvis
Patients who received chemotherapy for abdominal or pelvic cancer
Patients who received chemotherapy for breast cancer within 3 years since last chemotherapy
Patients who have the history of malignancy other than mentioned above within 5years
5) Patients with serious complications
Examples: Severe cardiac disease, celebro-vascular disorder, uncontrollable diabetes and/or hypertension, severe infections, pulmonary fibrosis, interstitial pneumonia, bleeding or active peptic ulcer, or double cancer, or severe neurological disease.
6) Patients with severe hypersensitivities
7) Patients with history of hypersensitivity reactions to polyoxyethylated castor oil
8) Patients with obvious infectious disease
9) Patients with peripheral (sensory or motor) neuropathy Grade 2or greater
10) Patients with clinical psycho-neurological disease
11) Patients who are pregnant or breast feeding or possibility of pregnancy
12) Patients with receiving experimental medicine at the time of entry
13) Patients whom investigators determined it impossible to complete the protocol treatment safely
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Fujiwara
Organization Saitama Medical University International Medical Center
Division name Gynecologic Oncology
Zip code
Address 1397-1 Yamane, Hidaka-City, Saitama, Japan
TEL 042-984-4637
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Fujiwara
Organization Saitama Medical University International Medical Center
Division name Gynecologic Oncology
Zip code
Address 1397-1 Yamane, Hidaka-City, Saitama, Japan
TEL 042-984-4637
Homepage URL
Email dofmet-office@umin.ac.jp

Sponsor
Institute Development Organization for Frontier Medical Therapeutics
Institute
Department

Funding Source
Organization Saitama Medical University International Medical Center
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 DOFMET Protocol #4
Org. issuing International ID_1 Development Organization for Frontier Medical Therapeutics
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 02 Month 16 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
Date of protocol fixation
2009 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2012 Year 02 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 02 Month 16 Day
Last modified on
2009 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002066

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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