STUDY OF THE mTOR INHIBITOR TEMSIROLIMUS (CCI-779) IN PATIENTS WITH CA125 ONLY RELAPSE OF OVARIAN CANCERA phase II study by the Hellenic Cooperative Oncology Group
- Conditions
- Ovarian cancerMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer
- Registration Number
- EUCTR2008-007925-38-GR
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 38
1.Histologic proof of epithelial ovarian carcinoma
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 patients of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment and use adequate methods of contraception
12.At least one month from the last chemotherapy administration.
11.Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
12. 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
13. 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
15. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method