UMIN-CTR Clinical Trial

Public title

Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer

Acronym

Phase I-II study of Irinotecan and Gemcitabine for recurrent ovarian cancer

Scientific Title

Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer

Scientific Title:Acronym

Phase I-II study of Irinotecan and Gemcitabine for recurrent ovarian cancer

Region

Japan

Condition

taxane/platinum resistant ovarian, fallopian tube and peritoneal cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

The Objective is to evaluate the feasibility of combination chemotherapy with Irinotecan and Gemcitabine for recurrent ovarian, fallopian tube or peritoneal cancer and to determine the recommended dose (Phase I). In Phase II study, the objective is to evaluate the response rate of this chemothearpy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Recommended Dose
Response Rate

Key secondary outcomes

Safety
Overall Survival
Progression Free Survival

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

A combination chemotherapy with Irinotecan (80-100 mg/m2) and Gemcitabine (800-1000 mg/m2) is administered on days 1 and 8 every 3 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 ovarian, fallopian tube or peritoneal cancer whose diagnoses were confirmed by pathologically.
2)
a)PD or SD status less than 6 months after taxane/platinum chemotherapy.
b)Recurrence less than 6 months after taxane/platinum chemotherapy.
3)
a)Prior chemotherapy should be within 2 regimens.
b)Patients who were not administered Irinotecan or Gemcitabine.
c)No chemotherapy within 4 weeks prior to the registration.
4)Patients who have not received radiotherapy.
5)Patients who have measurable disease.
6)Performance Status (ECOG):0-2
7)Patients who are 20 years old or older and younger than 75 years old.
8)Patients who are expected to survive at least 3 months.
9)Patients wh have adequate bone marrow, cardiac, respiratory, hepatic , and renalfunction .
10)Patients who have signed an approved informed consent.
11)Patients who's UGT1A1 genotypes were evaluated.

Key exclusion criteria

1)Patients who have a history of severe hypersensitivity to drug.
2)Patients with interstitial pneumonia.
3)Patients who have mmasive ascites and/or pleural effusion.
4)Patients who have severe infectious diseases.
5)Patients with other malignant disease.
6)Women at pregnant state or possibly pregnant women.
7)Patients with mental diseases.
8)Patients with symptomatic brain metastasis.
9)Patients with severe coronary disease.
10) Patients with uncontrollable diabetic disease.
11)Patients with watery diarrhea.
12)Patients with severe ileus.
13)Patients with intestinal bleeding.
14)Patients with positeve HBs antigen.
15)Patients with severe medical complications.
16)Patients with systematic edema.
17)Patients who are considered inappropriate for this study by the doctor.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Kiyoshi Yoshino

Organization

Osaka university, faculty of medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3351

Email

yoshino@gyne.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kiyoshi Yoshino

Organization

Osaka university, faculty of medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3351

Homepage URL

Email

yoshino@gyne.med.osaka-u.ac.jp

Institute

Osaka university, faculty of medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

大阪大学医学部附属病院

Date of disclosure of the study information

2011

Year

07

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29080971

Number of participants that the trial has enrolled

Results

PURPOSE:
To develop a new therapeutic strategy for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers, we evaluated the feasibility and efficacy of irinotecan and gemcitabine combination chemotherapy.
METHODS:
Patients with taxane/platinum-resistant/refractory cancer received escalating doses of irinotecan and gemcitabine (level 1: 80 and 800 mg/m2, respectively; level 2: 100 and 1000 mg/m2) on days 1 and 8 on a 21-day cycle. Genotyping for UGT1A1*6 and *28 polymorphisms was performed for possible adverse irinotecan sensitivity.
RESULTS:
A total of 35 patients were enrolled. The recommended dose was defined as 100 mg/m2 irinotecan and 1000 mg/m2 gemcitabine (level 2). The observed common grade 3/4 toxicities were neutropenia (60%), anemia (17.1%), diarrhea (8.6%), thrombocytopenia (5.7%) and nausea (5.7%). Groups homozygous for UGT1A1*6 or *28 were associated with grade 3/4 neutropenia and diarrhea. Objective responses were 20%, including one complete response and six partial responses. In 29 patients treated with the recommended dose, the median progression-free survival and overall survival were 3.8 months (95% CI 2.1-6.0 months) and 17.4 months (95% CI 9.9-21.9 months), respectively, while the 1-year survival rate was 58.6%.
CONCLUSIONS:
Combination chemotherapy with irinotecan and gemcitabine represents a safe and effective treatment combination for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers.

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

Completed

Date of protocol fixation

2011

Year

06

Month

17

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

2017

Year

03

Month

31

Day

Date trial data considered complete

2017

Year

04

Month

30

Day

Date analysis concluded

2017

Year

06

Month

15

Day

Other related information

Registered date

2011

Year

07

Month

05

Day

Last modified on

2018

Year

02

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007000