| Trial ID # | NCT00429793 |
| Phase | II |
| Drug Class | Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR |
| Drug Name | Temsirolimus |
| Alternate Drug Names | Torisel, CCI-779 |
| Drugs in Trial | Temsirolimus |
| Eligible Participant | Persistent or recurrent ovarian cancer, 1-3 prior cytoxic therapies |
| Patients Enrolled | 54; median 2 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, OS, evaluated per RECIST |
| Biomarkers | Exploratory: p-AKT, p-mTOR, p-4EBP1, pp70-S6K, Cyclin D1, CTC |
| Efficacy | ORR: 9.3% (5PR) |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | Modest activity; phase III not warranted in unselected patients; CCND1 positivity associated with longer PFS |
| Reference | Behbakht K et al. Phase II trial of the mTOR inhibitor, temsirolimus and evaluation of circulating tumor cells and tumor biomarkers in persistent and recurrent epithelial ovarian and primary peritoneal malignancies: a Gynecologic Oncology Group study. Gynecol Oncol (2011) 123(1):19-26 |