Phase II Trial in Platinum-Refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy
This study in patients with ovarian cancer refractory to platinum based chemotherapy is
designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study
to select the better dose and schedule arm for further investigation.
72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5
mg/day continuously or 50mg/day for 4 weeks followed by 14 days off.
Patients will get outpatients treatment. At screening the patients' eligibility will be
assessed, their baseline and demographic characteristics obtained, and the baseline values
for the effect variables collected. Patients with measurable lesions as well as
non-measurable disease will be included into this trial. Measurable lesion will be
documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by
analysis of CA°125 levels.
The patients' safety will be monitored during and up to 30 days after termination of SU11248
In patients with measurable lesions at baseline, the (post)-treatment values for effect
according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR,
a confirmatory CT or MRI scan is required after an interval of at least four weeks.
Antitumor effects according to CA°125 levels will be determined in the same time intervals
and, in addition, 28 days after last SU11248 application in patients with CA°125 response
according to GCIG guidelines during therapy.
For post study follow-up, patients and/or their physicians will be contacted via phone for
overall survival and TTP (including the method of diagnosis and additional treatment) every
2 months for their life time.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate
Uwe Wagner, MD, PhD
Universitätsklinikum Gießen u. Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie
Germany: Federal Institute for Drugs and Medical Devices