UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005798 |
|---|---|
| Receipt number | R000006862 |
| Scientific Title | Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer. |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2014/02/08 08:27:07 |
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Basic information
Public title
Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.
Acronym
Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.
Scientific Title
Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.
Scientific Title:Acronym
Phase I study of pegylated liposomal doxorubicin and cisplatin combination chemotherapy in patients with recurrent and refractory epithelial ovarian cancer.
Region
| Japan |
Condition
Condition
epithelial ovarian cancer, primary fallopian tube cancer, primary peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Objective is to evaluate the feasibility of administering a combination of pegylated liposomal doxorubicin(PLD) and cisplatin(CDDP) and to determine the maximum tolerated dose(MTD) and the recommended dose(RD) for Phase II trial of this combination.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To determine the maximum tolerated dose(MTD) and the recommended dose(RD)
Key secondary outcomes
The incidence of adverse effects
The efficacy of chemotherapy (Disease control rate over 4 months)
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 with pegylated liposomal doxorubicin and cisplatin
1)Dose level of CDDP
Level-1 30mg/m^2
Level 1 40mg/m^2
Level 2 50mg/m^2
Level 3 60mg/m^2
Level 4 70mg/m^2
In each dose levels, CDDP will be administered intravenously on day1.
2)PLD will be administered intravenously on day2, at a dose of 40mg/m^2.
Treatment cycles are repeated every 28 days until disease progression, unless the dose level is considered as the DLT in the first cycle.
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 histological or clinical diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
2) FIGO stage: I-IV
Recurrence or refractory after previous systemic chemotherapy.
No prior chemotherapy with PLD
3) Age: 20-75 years old
4) ECOG Performance Status: 0-1
5) Patients with/without measureable disease.
6) Adequate organ function
ANC: more than or equal to 1500/mm3
Plt: more than or equal to 100,000/mm3
T.Bil: less than or equal to 1.5mg/dl
AST(GOT): less than or equal to 100IU/L
ALT(GPT): less than or equal to 100IU/L
S-Cr: less than or equal 1.2mg/dl
ECG: within normal limits
LVEF: 50% or more
7) Patients must have signed informed consent of this trial.
Key exclusion criteria
1)No evidence of interstitial pneumonitis or pulmonary fibrosis on chest X-ray or CT.
2)Patients with a history of severe hypersensitivity reactions to any drugs.
3)Patients with severe heart disease.
4)Patients with active autoimmune disease.
5)Patients with prior diagnosis of malignancy.
Exceptios are:
- carcinoma in situ
- other malignancies curatively treated and >5 years without evidence of recurrence.
6)Patients with an active or uncontrolled infection.(without chronic viral hepatitis.)
7)Patients with other severe deisease(e.g.,renal failure, liver failure, gastrointestinal ulcer)
8)Patienst with massive ascites or/and pleural effusion.
9)Patients with history of hypersensitivity reactions to cisplatin or other platinum.
10) No prior cumulative anthracycline dose in excess of 250mg/m^2.
11)Patients who are decided to be ineligible for this trial by the investigators.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruko Iwase |
Organization
Cancer Institute Hospital
Division name
Department of Gynecology
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
hiwase-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruko Iwase |
Organization
Cancer Institute Hospital
Division name
Department of Gynecology
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
haruko.iwase@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
がん研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 18 | Day |
Last modified on
| 2014 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006862
