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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005926

Enrollment

Registered

2011-07-05

Start date

2011-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

taxane/platinum resistant ovarian, fallopian tube and peritoneal cancer

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Recommended Dose Response Rate	—

Secondary

Measure	Time frame
Safety Overall Survival Progression Free Survival	—

Countries

Japan

Contacts

Public ContactKiyoshi Yoshino

Osaka university, faculty of medicine Department of Obstetrics and Gynecology

yoshino@gyne.med.osaka-u.ac.jp06-6879-3351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026