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

This study has been 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)
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00926107
First received: June 22, 2009
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hellenic Cooperative Oncology Group:

Primary Outcome Measures:
  • Clinical progression free survival. [ Time Frame: 6-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS),Survival, CA125 response rate, Safety [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Temsirolimus
    Temsirolimus 25mg weekly until clinical progression
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926107

Locations
Greece
"Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology
Athens, Greece, 11528
"Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section
Athens, Greece, 12461
Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
Athens, Greece
Hygeia Hospital, 1st Dept. of Medical Oncology
Athens, Greece, 15123
Hygeia Hospital, 2nd Dept. of Medical Oncology
Athens, Greece, 15123
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
  More Information

No publications provided

Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00926107     History of Changes
Other Study ID Numbers: HE 4/09, 2008-007925-38
Study First Received: June 22, 2009
Last Updated: November 9, 2011
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014