Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)

Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy) - Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006999

Enrollment

Registered

2012-01-01

Start date

2046-12-31

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Patients with platinum refractory and resistant Mullerian carcinoma (ovarian cancer, fallopian tubal, primary peritoneal cancer)

Interventions

Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Irinotecan dose was fixed at 50 mg/ m2. In tailored dose chemotherapy arm gemcitabine dose was tailored to

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma) 2)Prior two regimens chemotherapy is required. Platinum-resistant disease is based on the most recent exposure to a platinum-based regimen and is defined as progressive disease within 6 months of completing the prior therapy. 3)Patients have at least one measurable disease. 4)No chemotherapy within 2 weeks prior to the registration 5)Patients who are 20 years old or older and younger than 79 years old at the enrollment 6)Performance status:ECOG 0-2 7)Adequate bone marrow, renal, and hepatic function 8)Patients who are expected to survive more than 3 months. 9)Patients who have signed an approved informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who have a history of hypersensitivity to gemcitabine and irinotecan. 2)Patients with active infection 3)Patients with severe complications (Heart disease, uncontrolleddiabetes, malignant hypertension, or bleeding tendency) 4)Patients with other cancer within the past 5 years 5)Patients with myocardial infarction within 6 months or angina attack. 6)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Adverse event Response Rate ( disease control rate) Overall Survival Tolerability Patient QOL	—

Countries

Japan

Contacts

Public ContactShinichi Tate , M.D.

Chiba University Hospital Department of Gynecology

state@faculty.chiba-u.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026