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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000115 |
Receipt No. | R000000171 |
Scientific Title | A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma) |
Date of disclosure of the study information | 2005/09/09 |
Last modified on | 2013/02/12 |
Basic information | ||
Public title | A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma) | |
Acronym | Weekly IP PAC+CBDCA for mullerian carcinoma | |
Scientific Title | A phase I/II study of weekly intraperitoneal paclitaxel +monthly intravenous carboplatin for mullerian carcinoma (ovarian, tubal, and peritoneal carcinoma) | |
Scientific Title:Acronym | Weekly IP PAC+CBDCA for mullerian carcinoma | |
Region |
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Condition | ||
Condition | Gynecological Mullerian tumors, such as ovarian, tubal, and peritoneal cancers. | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | We conducted a phase I/II study of combination regimen with weekly ip-Paclitaxel (PAC) and monthly intravenous carboplatin(Carbo) to define the recommended dose (RD) and toxicity profiles as well as usefullness. |
Basic objectives2 | Others |
Basic objectives -Others | Assessment of pharmakokinetics and progression free survival time |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | definition of recommended dose and assessment of feasibility of the treatment |
Key secondary outcomes | response (using CA125 according to Rustin's criteria, reduction of ascitic fluid), time to progression
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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 |
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Interventions/Control_1 | An estimation of MTD/RD of intraperitoneal administration with paclitaxel weekly in Carboplatin/paclitaxel regimens for optimal debulked ovarian cancer. | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | (1)Histological diagnosed gynecological Mullerian cancers,such as ovarian, tubal, and peritoneal cancer stage over IC(IC-IV) or recurrent disease with pelvic disease (retention of ascitic fluid, para-aortic nodes recurrence) with optimal debulked surgery.
(2)Adequate organ function with; ANC>1,500/mm3, platelets>100,000/mm3,Hb>9.0g/dl, S-GOT,GPT< 2 times of normal range,T-bil<1.5mg/dl, S-Crn < 1.5mg/dl,or Creatinin Clearance (CCr) > 40ml/min. EKG:normal, without heart disease and severe arhythmia (3)ECOG Performance Status 0-2 (4)Patients expected to survive at least 6 months (5)Patients who will be gotten fully informed consent for the clinical study |
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Key exclusion criteria | (1)Whom not to be suitable for eligibility criateria
(2)Known severe hypersensitivityor having past illness of hypersensitivity to any drug (3)pregnant,milk-feeding woman or who is expected to be pregnant (4)Who have too much pleural effusion or pericardial effsion. (5)Known hypersensitivity to these drugs(paclitaxel, and/or carboplatin) or to agent containing polyoxiethilene cremophol such as cyclosporine injection |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Natinonal Hospital Organization Kobe Medical Center | ||||||
Division name | Gynecologic Oncology | ||||||
Zip code | |||||||
Address | 3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan | ||||||
TEL | 078-791-0111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Natinonal Hospital Organization Kobe Medical Center | ||||||
Division name | Gynecologic Oncology | ||||||
Zip code | |||||||
Address | 3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan | ||||||
TEL | 078-791-0111 | ||||||
Homepage URL | |||||||
s-take-kmc@zeus.eonet.ne.jp |
Sponsor | |
Institute | Natinonal Hospital Organization Kobe Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Grant of Ntional Cancer Center Hospital:Grant for cancer study 2002 from Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Osaka Medical College, Kobe University, Iwate Medical University, Tottori University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | By now 12 patients were recruited, and all patients were completed. As for pharmacokinetics and adverse events the results were reported at 2004 ASCO procedings. At ECCO 12 meeting the presentation was made according to the results except for survival. The survivals and outcome would be reported soon. |
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 | ||||||
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | No treatments related death were observed. Unexpected adverse events have not observed. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000171 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |