UMIN-CTR Clinical Trial

Public title

A Phase II Trial of Liposomal Doxorubicin (PLD, DOXILTM) as 3rd Line Treatment in Relapsed, Plutinum - resistant Ovarian Cancer

Acronym

A Phase II Trial of Liposomal Doxorubicin (PLD, DOXILTM) as 3rd Line Treatment in Relapsed, Plutinum - resistant Ovarian Cancer

Scientific Title

A Phase II Trial of Liposomal Doxorubicin (PLD, DOXILTM) as 3rd Line Treatment in Relapsed, Plutinum - resistant Ovarian Cancer

Scientific Title:Acronym

A Phase II Trial of Liposomal Doxorubicin (PLD, DOXILTM) as 3rd Line Treatment in Relapsed, Plutinum - resistant Ovarian Cancer

Region

Japan

Condition

Ovarian Cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A purpose of this study is to evaluate the efficacy and safety of PLD 40 mg/m2 administered intravenously every 4 weeks to patients with Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a 2ed time therapeutic history of platinum-based chemotherapy using best overall response (response rate) as a primary endpoint.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Best overall response (Response rate)

Key secondary outcomes

1. The incidence and the degree of adverse events and adverse drug reactions, etc.2. The median duration of response and the range, etc. in response cases (CR or PR)3. The median time to response and the range, etc. in response cases (CR or PR)4. The median time to death and the range, etc. in response cases (CR or PR)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

PLD 40 mg/m2 administere intravenously every 4 weeks

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Female

Key inclusion criteria

1)Patients with a diagnosis of Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) established by a histologic examination.
2) Patients who received the initial platinum-based chemotherapy and patients who use PLD as third-line therapy
3) Patients having a disease progression within 12 months (365 days when the next day of the final treatment with a platinum based chemotherapy is treated as the 1st day) after the final treatment with a first-line platinum based chemotherapy (excluding those with the best response to the first-line platinum-based chemotherapy evaluated as PD).
4) Patients with measurable lesions meeting RECIST criteria.
5) Patients who are at least 20 years of age and younger than 75 years of age at the enrollment.
6) Patients with ECOG Performance Status (abbreviated as P.S., hereafter) 0-2.
7) Patients who have adequate major organ functions and fulfill all of the following criteria in order to evaluate the efficacy and safety of PLD.
Neutrophils (total neutrophil count): > or = 1,500/mm3
Hemoglobin: > or = 19.0g/dL
Platelet: > or = 1100,000/ mm3
Serum GOT (AST), GPT (ALT): < or = 2.5 times the upper limit of institutional normal range
Serum ALP: < or = 2.5 times the upper limit of institutional normal range
Total bilirubin: > 1.2mg/dL
Serum creatinine: < or = 1.5 times the upper limit of institutional normal range
Cardiac function LVEF: > or = 50%Electrocardiograph: Normal or clinical irrelevant change
8) Patients judged to have at least 3-month life expectancy.
9) Patients who give consent of their own will in writing after being given a sufficient explanation by the investigator (or subinvestigator) about the contents of the study using the prescribed informed consent form and other explanatory documents.

Key exclusion criteria

1)Pregnant women, nursing mothers, and those who may be or are willing to be pregnant.
2)Patients with active double cancer (synchronic double cancer and asynchronous double cancer with no more than 5-year disease-free period. However, basal cell carcinoma in the skin, squamous cell carcinoma, and carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer).
3)Patients with a severe psychiatric disorder that is considered to interfere with the conduct of this study.
4)Patients with concomitant disease that may affect the conduct of the study and the evaluation of PLD (severe one, or active and systemic infection, etc.).
5)Patients who had myocardial infarction and angina attack within 90 days (if the previous day of the enrollment is the initial date of reckoning, up to 90 days before).
6)Uncontrolled or severe cardiovascular disease including myocardial infarction.
7)Patients who have received bone marrow transplantation or have a therapeutic history of massive chemotherapy + hematopoietic stem cell transplantation.
8)Patients receiving, as prior therapy, anthracycline treatment exceeding 250 mg/m2 as a total doxorubicin equivalent dose.
9)Patients with a poorly controlled restrictive or obstructive pulmonary disease.
10)Patients with symptomatic brain metastasis.
11)Patients who are already receiving treatment with PLD.
12)Patients with a history of severe hypersensitivity.
13)Patients with a past history of hypersensitivity to doxorubicin products and any ingredients of PLD (MPEG-DSPE, soybean hydrogenised phospholipids, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydrochloride).
14)Other patients judged ineligible as subjects for the clinical study by the investigator (or subinvestigator).

Target sample size

43

Name of lead principal investigator

1st name
Middle name
Last name	Masami Fujita

Organization

Osaka University Faculty of Medicine

Division name

Department of obstetrics and gynecology

Zip code

Address

2-2 Yamadaoka Suita Osaka

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Faculty of Medicine

Division name

Department of obstetrics and gynecology

Zip code

Address

TEL

Homepage URL

Email

Institute

Osaka University Faculty of Medicine
Department of obstetrics and gynecology

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2009

Year

08

Month

18

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

11

Month

30

Day

Last modified on

2009

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003177