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Ovarian CancerPhase 2NCT00926107

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

A Phase 2 study testing Temsirolimus in people with Ovarian Cancer, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Temsirolimus
How many people
9 participants
Where
12 sitesGreece
Study dates
Jun 2009to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the following histological types:serous, endometrioid, mucinous, clear cell, low differentiation.
  • Age 18 years or older
  • Patients should have received first-line platinum based chemotherapy
  • Documented CA125 progression according to GCIC criteria.
  • No evidence of measurable or evaluable disease.
  • Provision of written informed consent
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  • ECOG PS 0-2
  • Life expectancy of greater than 12 weeks
  • 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.
  • 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.
  • At least one month from the last chemotherapy administration.
  • Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).

Who cannot join

  • Other histological types (germ cell, granulose tumors etc)
  • 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
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
  • Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse)
  • History of any treatment for CA125 relapse
  • Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
Show all 13Show fewer
  • Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR.
  • 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
  • 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
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Greece12 sites

  • "Alexandra" Hospital, Dept. of Clinical Therapeutics, Oncology

    Athens, 11528

  • "Attikon" University Hospital, 2nd Dept. of Internal Medicine-Propaedeutic, Oncology Section

    Athens, 12461

  • Hygeia Hospital, 1st Dept. of Medical Oncology

    Athens, 15123

  • Hygeia Hospital, 2nd Dept. of Medical Oncology

    Athens, 15123

  • Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology

    Athens

  • Chania General Hospital, Oncology Dept.

    Chania, 73100

  • Ioannina University Hospital, Dept. of Medical Oncology

    Ioannina, 45110

  • Larissa University Hospital, Oncology Dept.

    Larissa, 41110

  • University Hospital of Patras, Oncology Dept

    Pátrai, 26500

  • Metropolitan Hospital, 1st Dept. of Medical Oncology

    Pireaus, 18547

  • Metropolitan Hospital, 2nd Dept. of Medical Oncology

    Pireaus, 18547

  • "Papageorgiou" General Hospital, Dept. of Medical Oncology

    Thessaloniki, 56429

Other trials in Greece

About this study

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.

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.

Conditions
Ovarian Cancer
Being tested
Temsirolimus
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemsirolimusDrug

    Temsirolimus 25mg weekly until clinical progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical progression free survival.

    Measured: 6-month

Secondary outcomes (1)

  1. Progression Free Survival (PFS),Survival, CA125 response rate, Safety

    Measured: Duration of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2011
  4. Study completionOct 2011

Why it stopped: The study ended prematurely due to the low accrual rate (24% of the expected accrual rate) in the first two years of patients enrolment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00926107
Sponsor's protocol ID
HE 4/09
Other IDs
2008-007925-38, 2008
Status last verified
Nov 2011
First submitted
22 Jun 2009
Last updated
10 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temsirolimus in people with Ovarian Cancer, run by Hellenic Cooperative Oncology Group at 12 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study ended prematurely due to the low accrual rate (24% of the expected accrual rate) in the first two years of patients enrolment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical progression free survival. (time frame: 6-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.

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