UMIN-CTR Clinical Trial

Public title

Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial)

Acronym

Phase I trial of CPT-11/PLD for recurrent ovarian cancer

Scientific Title

Dose finding study of the combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with recurrent ovarian cancer (Phase I trial)

Scientific Title:Acronym

Phase I trial of CPT-11/PLD for recurrent ovarian cancer

Region

Japan

Condition

Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer recurred during the present chemotherapy or within 6 months after the prior chemotherapy.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the maximum tolerated dose (MTD) and the domestic recommended dose (RD) of irinotecan hydrochloride and pegylated liposomal doxorubicin combination therapy in patients with epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer recurred during the present chemotherapy or within 6 months after the prior chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

The maximum tolerated dose of combination chemotherapy consisting of irinotecan hydrochloride and pegylated liposomal doxorubicin.

Key secondary outcomes

The incidence of adverse events and Response Rate.

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

Combination chemotherapy consisting of irinotecan hydrochloride (the following dose level, on day1, 8 and 15) and pegylated liposomal doxorubicin (40 mg/m^2, on day3) will be administered intravenously every 4 weeks.
Dose level of irinotecan
Level-1 40mg/m^2
level 1 50mg/m^2
level 2 60mg/m^2
level 3 70mg/m^2
Patients is planned to receive at least 4 cycles of combination treatment and 12 cycles as the upper limit unless disease progression or unacceptable toxicity is observed.

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

80

years-old

>

Gender

Female

Key inclusion criteria

1. Patients with a histologic diagnosis of epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
2. Patients who received chemotherapy consisting of platinum.
3. Patients with platinum resistant/refractory recurrent disease.
4. Patients who received chemotherapy within two regimens.
5. ECOG Performance Status: 0-1.
6. Reasonable organ function.
WBC: 3,000-12,000/mm3
ANC: >1,500/mm3
Hb: >10.0g/dL
Platelet: >100,000/mm3
AST, ALT: less than or equal to 2.5x institutional ULN
ALP: less than or equal to 2.5x institutional ULN
Bilirubin: less than or equal to 1.5x institutional ULN
Serum creatinine: less than or equal to 1.5x institutional ULN
No suffering from diarrhea
LVEF: 50% or more
ECG: within normal limits
7. Patients who do not be administered CSF or transfused within two weeks at registration.
8. Patients who have the following periods.
4 weeks or more after the prior surgery
4 weeks or more after the prior radiotherapy
2 weeks or more after the prior chemotherapy, such as hormonal drug, oral antimetabolite, immunetherapy.
6 weeks or more after the prior chemotherapy, such as nitrosourea and mitomycin C.
4 weeks or more after other prior chemotherapy.
9. Patients expected of three months or more survival.
10. Age: 20 years old or older, and under 80 years old.
11. Patients must have signed informed consent.

Key exclusion criteria

1. Patients with severe complications or active infection.
2. Patients with prior diagnosis of malignancy are not eligible. Exceptions are:
-non-melanoma skin cancer, and carcinoma in situ.
-other malignancies curatively treated and > 5 years without evidence of recurrence.
3. Patients with massive pleural effusion and/or ascites.
4. Patients with massive pericardial fluid.
5. Patients with unstable angina or those who have had a myocardial infarction within the past 90 days.
6. Patients who have received prior chemotherapy consisting of irinotecan or anthracyclins.
7. Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic.
8. Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation.
9. Patients who have participated in other clinical trials.
10. Patients with history of hypersensitivity reactions to irinotecan or the components of pegylated liposomal doxorubicin.
11. Patients who are pregnant, lactating, and have pregnant possibility or intention.
12. Patients with diarrhea or watery stool.
13. Patients with bowel paralysis or obstruction.
14. Patients with apparent interstitial pneumonitis or pulmonary fibrosis on chest X-ray.
15. Patients who are receiving Atazanavir.
16. Patients who have genetic polymorphism of homo UGT1A1*6 or *28, or hetero UGT1A1*6 and *28
17. Patients who are decided to be ineligible for this trial by the investigators.

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Aoki

Organization

School of Medicine, Keio University

Division name

Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo, 160-8582

TEL

03-3353-1211(ext.62391)

Email

Name of contact person

1st name
Middle name
Last name	Hiroshi Tsuda

Organization

School of Medicine, Keio University

Division name

Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo, 160-8582

TEL

03-5363-3819

Homepage URL

Email

htsud@sc.itc.keio.ac.jp

Institute

School of Medicine, Keio University Obstetrics and Gynecology

Institute

Department

Personal name

Organization

Janssen Pharmaceutical K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

St. Marianna University, School of Medicine

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

慶應義塾大学医学部　産婦人科（東京都）
聖マリアンナ医科大学　産婦人科（東京都)

Date of disclosure of the study information

2010

Year

11

Month

22

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

Terminated

Date of protocol fixation

2010

Year

09

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

22

Day

Last modified on

2012

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005495