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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926107
Recruitment Status : Terminated (The study ended prematurely due to the low accrual rate (24% of the expected accrual rate) in the first two years of patients enrolment)
First Posted : June 23, 2009
Last Update Posted : November 10, 2011
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Temsirolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Intervention Details:
  • Drug: Temsirolimus
    Temsirolimus 25mg weekly until clinical progression

Primary Outcome Measures :
  1. Clinical progression free survival. [ Time Frame: 6-month ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS),Survival, CA125 response rate, Safety [ Time Frame: Duration of the study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926107

"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology
Athens, Greece, 11528
"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section
Athens, Greece, 12461
Hygeia Hospital, 1st Dept. of Medical Oncology
Athens, Greece, 15123
Hygeia Hospital, 2nd Dept. of Medical Oncology
Athens, Greece, 15123
Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
Athens, Greece
Chania General Hospital, Oncology Dept.
Chania, Greece, 73100
Ioannina University Hospital, Dept. of Medical Oncology
Ioannina, Greece, 45110
Larissa University Hospital, Oncology Dept.
Larissa, Greece, 41110
University Hospital of Patras, Oncology Dept
Patras, Greece, 26500
Metropolitan Hospital, 1st Dept. of Medical Oncology
Pireaus, Greece, 18547
Metropolitan Hospital, 2nd Dept. of Medical Oncology
Pireaus, Greece, 18547
"Papageorgiou" General Hospital, Dept. of Medical Oncology
Thessaloniki, Greece, 56429
Sponsors and Collaborators
Hellenic Cooperative Oncology Group

Responsible Party: Hellenic Cooperative Oncology Group Identifier: NCT00926107     History of Changes
Other Study ID Numbers: HE 4/09
2008-007925-38 ( EudraCT Number )
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents