UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001713 |
|---|---|
| Receipt number | 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 17:28:22 |
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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
| Obstetrics 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
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
dofmet-office@umin.ac.jp
Sponsor or person
Institute
Development Organization for Frontier Medical Therapeutics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002066
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