Clinical trial NCT00926107: Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Clinical progression free survival.
timeFrame: 6-month
Secondary outcomes:
measure: Progression Free Survival (PFS),Survival, CA125 response rate, Safety
timeFrame: Duration of the study
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology
city: Athens
country: Greece
facility: "Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section
city: Athens
country: Greece
facility: Hygeia Hospital, 1st Dept. of Medical Oncology
city: Athens
country: Greece
facility: Hygeia Hospital, 2nd Dept. of Medical Oncology
city: Athens
country: Greece
facility: Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
city: Chania
country: Greece
facility: Chania General Hospital, Oncology Dept.
city: Ioannina
country: Greece
facility: Ioannina University Hospital, Dept. of Medical Oncology
city: Larissa
country: Greece
facility: Larissa University Hospital, Oncology Dept.
city: Patras
country: Greece
facility: University Hospital of Patras, Oncology Dept
city: Pireaus
country: Greece
facility: Metropolitan Hospital, 1st Dept. of Medical Oncology
city: Pireaus
country: Greece
facility: Metropolitan Hospital, 2nd Dept. of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Papageorgiou" General Hospital, Dept. of Medical Oncology
Study officials:
References: