Status:
TERMINATED
Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse
Lead Sponsor:
Hellenic Cooperative Oncology Group
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the efficacy of Temsirolimus in patients with ovarian cancer with CA125 only relapse after first-line platinum-based chemotherapy.
Eligibility Criteria
Inclusion
- Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the following histological types:serous, endometrioid, mucinous, clear cell, low differentiation.
- Age 18 years or older
- Patients should have received first-line platinum based chemotherapy
- Documented CA125 progression according to GCIC criteria.
- No evidence of measurable or evaluable disease.
- Provision of written informed consent
- ECOG PS 0-2
- Life expectancy of greater than 12 weeks
- 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.
- 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.
- At least one month from the last chemotherapy administration.
- Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).
Exclusion
- Other histological types (germ cell, granulose tumors etc)
- 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
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse)
- History of any treatment for CA125 relapse
- Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
- Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR.
- 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
- 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
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00926107
Start Date
June 1 2009
End Date
October 1 2011
Last Update
November 10 2011
Active Locations (12)
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1
"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology
Athens, Greece, 11528
2
"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section
Athens, Greece, 12461
3
Hygeia Hospital, 1st Dept. of Medical Oncology
Athens, Greece, 15123
4
Hygeia Hospital, 2nd Dept. of Medical Oncology
Athens, Greece, 15123