Phase I/II Trial of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer

Trial ID # UMIN000004449
Phase II
Drug Class Chemotherapy
Drug Name Gemcitabine
Alternate Drug Names Gemzar
Drugs in Trial Gemcitabine, Irinotecan
Eligible Participant

Platinum resistant or refractory ovarian cancer with ≥ 2 prior platinum regimens; no primary platinum resistant or refractory

Patients Enrolled

25, median 2 prior therapies

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, OS, evaluated per RECIST


ORR: 20% (1CR, 4PR, n=25)
DCR: 76% (1CR, 4PR, 14SD)
PFS: 6.2 months
OS: 16.8 months
PFS at 6 months: 48%

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: neutropenia (11%)


Tailored-dose chemotherapy with gemcitabine+irinotecan is effective and well tolerated in patients with platinum-refractory/resistant ovarian cancer


Tate S et al. Tailored-dose chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer: a phase II trial. J Gynecol Oncol (2021) 32(1):e8

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