A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, OS, evaluated per RECIST


Exploratory: p-AKT, p-mTOR, p-4EBP1, pp70-S6K, Cyclin D1, CTC


ORR: 9.3% (5PR)
DCR: 50% (5PR, 22SD)
PFS: 3.2 months
PFS (≥ 6 months): 24%
OS: 11.6 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: metabolic (15%), gastrointestinal (15%), pain (11%)


Modest activity; phase III not warranted in unselected patients; CCND1 positivity associated with longer PFS


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

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