Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse
NCT ID: NCT00926107
Last Updated: 2011-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2009-06-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Temsirolimus
Temsirolimus 25mg weekly until clinical progression
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Hellenic Cooperative Oncology Group
OTHER
Responsible Party
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Locations
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"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology
Athens, , Greece
"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section
Athens, , Greece
Hygeia Hospital, 1st Dept. of Medical Oncology
Athens, , Greece
Hygeia Hospital, 2nd Dept. of Medical Oncology
Athens, , Greece
Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
Athens, , Greece
Chania General Hospital, Oncology Dept.
Chania, , Greece
Ioannina University Hospital, Dept. of Medical Oncology
Ioannina, , Greece
Larissa University Hospital, Oncology Dept.
Larissa, , Greece
University Hospital of Patras, Oncology Dept
Pátrai, , Greece
Metropolitan Hospital, 1st Dept. of Medical Oncology
Pireaus, , Greece
Metropolitan Hospital, 2nd Dept. of Medical Oncology
Pireaus, , Greece
"Papageorgiou" General Hospital, Dept. of Medical Oncology
Thessaloniki, , Greece
Countries
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Other Identifiers
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2008-007925-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HE 4/09
Identifier Type: -
Identifier Source: org_study_id