Study of the mTOR Inhibitor Temsirolimus(CCI-779) in Patients With CA125 Only Relapse of Ovarian Cancer. A Phase II Study by the Hellenic Cooperative Oncology Group.
1. Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the
following histological types:serous, endometrioid, mucinous, clear cell, low
2. Age 18 years or older
3. Patients should have received first-line platinum based chemotherapy
4. Documented CA125 progression according to GCIC criteria.
5. No evidence of measurable or evaluable disease.
6. Provision of written informed consent
7. ECOG PS 0-2
8. Life expectancy of greater than 12 weeks
9. WBC>4000/μl, platelets > 100,000/μl and a hemoglobin level > 9.5 g/dl. Adequate
baseline hepatic function, defined as a total bilirubin level < 2 mg/dl, SGPT and
SGOT < 2.5 times the upper limits of normal. Creatinine < 1.5 mg/dl or creatinine
clearance > 60 ml/min.
10. All females of childbearing potential must have a negative serum or urine pregnancy
test obtained within 2 days prior to initiation of treatment and use effective
contraception during the period of therapy.
11. At least one month from the last chemotherapy administration.
12. Provision of adequate paraffin-embedded tumor tissue for translational studies
1. Other histological types (germ cell, granulose tumors etc)
2. History of atrial or ventricular arrhythmias and/or history of congestive heart
failure, even if medically controlled. History of clinical and
electrocardiographically documented myocardial infarction within the last 6 months
from study entry
3. Any evidence of clinically active interstitial lung disease (patients with chronic
stable radiographic changes who are asymptomatic need not be excluded)
4. Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria
(intolerable paresthesia and/or marked motor loss or worse)
5. History of any treatment for CA125 relapse
6. Known, severe hypersensitivity to temsirolimus or any of the excipients of this
7. Other coexisting malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
9. As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
10. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5
times the ULRR.
11. Active infection or evidence of any other significant clinical disorder or laboratory
finding that makes it undesirable for the patient to participate in the trial/
receive protocol treatment
12. Concomitant use of Cyp3 A inducers (phenytoin, carbamazepine, rifampicin,
barbiturates or St John's Wort) should be avoided and as should treatment with strong
CyP 3A inhibitors
13. Treatment with a non-approved or investigational drug within 30 days before Day 1 of