Clinical trial NCT00926107 (phase 2, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: temsirolimus
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O
Reason stopped: 
    the study ended prematurely due to the low accrual rate (24% of the expected accrual rate) in
    the first two years of patients enrolment
  
Eligibility criteria:

        Inclusion Criteria:

          1. Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the
             following histological types:serous, endometrioid, mucinous, clear cell, low
             differentiation.

          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
             (optional).

        Exclusion Criteria:

          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
             product

          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
             therapy

          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
             trial treatment.