Study of the mTOR Inhibitor Temsirolimus (CCI-779) to Treat Ovarian Cancer With CA125 Only Relapse

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00926107
• Other study ID #: HE 4/09
• Secondary ID: 2008-007925-38
• Status: Terminated
• Phase: Phase 2
• First received: June 22, 2009
• Last updated: November 9, 2011
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Temsirolimus
Temsirolimus 25mg weekly until clinical progression

Locations

Country	Name	City	State
Greece	"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology	Athens
Greece	"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section	Athens
Greece	Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology	Athens
Greece	Hygeia Hospital, 1st Dept. of Medical Oncology	Athens
Greece	Hygeia Hospital, 2nd 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	Patras
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

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical progression free survival.		6-month	No
Secondary	Progression Free Survival (PFS),Survival, CA125 response rate, Safety		Duration of the study	Yes