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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: 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 individualized maximum repeatable dose. In optimal dose chemotherapy arm gemcitabine dose was tailored to maximum tolerated dose. CONDITION: Patients with platinum refractory and resistant Mullerian carcinoma (ovarian cancer, fallopian tubal, primary peritoneal cancer) PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: Adverse event ; Response Rate ( disease control rate) ; Overall Survival ; Tolerability ; Patient QOL 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.
Epistemonikos ID: 9909b30524bf207e6c95cb3597434851a61118f1
First added on: Aug 22, 2024