UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005926
Receipt number R000007000
Scientific Title Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer
Date of disclosure of the study information 2011/07/05
Last modified on 2018/02/06 17:26:24

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Basic information

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

Condition

taxane/platinum resistant ovarian, fallopian tube and peritoneal cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

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


Assessment

Primary outcomes

Recommended Dose
Response Rate

Key secondary outcomes

Safety
Overall Survival
Progression Free Survival


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Osaka university, faculty of medicine

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

大阪大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name