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Genital Diseases, FemalePhase 2NCT01460979

Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma

A Phase 2 study testing Temsirolimus in people with Genital Diseases, Female and Ovarian Diseases, run by AGO Study Group at 18 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
18 sitesGermany
Study dates
Oct 2011to Nov 2015
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

  • Women ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Before performance of study specific actions or assessment the patient has to be informed, has signed the written consent and is willing to follow the requirements concerning treatment and follow-up.Comment: Procedures which are according to common clinical routine and having been performed before having given written informed consent may be used for the purpose of screening procedures or initial medical assessment as long as these procedures follow the protocol.
  • Required: negative pregnancy test in fertile women
  • Stratum A - Ovarian Cancer:
  • Histologically confirmed Ovarian Cancer
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  • Platin-refractory relapsed disease: progression within a platin-based chemotherapy or within 6 months after completion of a platin-based chemotherapy
  • Prior treatment with a taxane-based scheme
  • minimum of one measurable or non-measurable tumor lesion(according to RECIST 1.1 criteria)
  • Not more than 2 previous chemotherapies or cytostatic therapies (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors)
  • Stratum B - Endometrian Cancer:
  • Histologically confirmed Endometrian Cancer
  • Advanced (International Federation of Gynaecology and Obstetrics (FIGO) III or IV) or relapsed diseases not amenable to potentially curative treatment with local surgery and/or radiation therapy
  • Prior endocrine therapy is allowed
  • Prior adjuvant chemotherapy is allowed
  • Minimum of one measurable or non-measurable tumor lesion(according to RECIST 1.1 criteria)

Who cannot join

  • ECOG > 2
  • Prior therapy with mammalian target of rapamycin (mTOR) -Inhibitor
  • Cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors), cytotoxical chemotherapy or endocrine therapy or radiation at the same time
  • Current or recent treatment with another study drug and/or participation in another clinical study within 28 days prior to first dose of study treatment
  • Chemotherapy or cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors) or radiation within 28 days prior to start of study treatment
  • Known or supposed hypersensitivity compared to study medication
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  • Acute or chronical infection
  • Second malignancy which influences the prognosis of the patient
  • Inadequate renal function (Creatinin > 1.5 x Upper Limit of Normal (ULN))
  • Inadequate liver function (aspartate transaminase (AST), alanine transaminase (ALT), gamma-Glutamyl transpeptidase (GGT) > 2.5 x ULN or > 5.0 x ULN in the presence of liver metastasis; Bilirubin > 1.5 x ULN)
  • Platelets < 100.000 /μl; Absolute Neutrophil Count (ANC) < 1.500 /μl
  • Cachectic patients with weight < 45kg
  • Patients who need parenteral nutrition
  • Patients with ileus within the last 28 days
  • One of the following diseases within 12 months prior to first study treatment: myocardial infarction, severe/unstable angina, bypass surgery of the coronar- or peripheral vessels, symptomatic heart insufficiency, cerebrovascular insult, transient ischemic attack (TIA), pulmonary embolism, deep venous thrombosis, other thromboembolic events
  • Current treatment with Cytochrome P450 3A4 (CYP3A4) -Inhibitors (i.e. protease inhibitors, antimycotics, calcium channel blocker, macrolide antibiotics, Cimetidine) or -inductors (i.e. Carbamazepin, Phenobarbital, Phenytoin, Rifampicin, amber)
  • Uncontrolled hypertension (> 150/100 mmHg despite optimal medicinal treatment)
  • Current cardiac arrhythmias (Common Terminology Criteria for Adverse Events of National Cancer Institute (NCI CTCAE) grade ≥ 2), atrial fibrillation, prolongation of QTc > 470 msec
  • Left ventricular ejection fraction (LVEF) ≤ 50% defined by echocardiogram
  • NCI CTCAE grade 3 hemorrhage within 4 weeks prior to beginning of treatment
  • Symptoms which indicate brain metastases, spinal cord compression or give new indications for brain- or leptomeningeal metastases
  • Human immunodeficiency virus (HIV) positive or manifested Acquired Immune Deficiency Syndrome (AIDS-disease)
  • Patients with other severe diseases who represent an inadequate risk for study participation
  • Applicable only for patients with no hysterectomy and/or bilateral adnexectomy prior to start of study.
  • lactation
  • potential fertile women without adequate contraception (potential fertile women must use one of the following adequate contraception: complete abstinence, intrauterine spiral or another method with a failure quote < 1% per year)
  • life expectancy < 3 months
  • neurological or psychiatric diseases or drugs or alcohol abuse which suppose no adequate comprehension and consequently no effective consent to study participation or no acceptable compliance during the study
  • predictable problems with the compliance to appointments for examinations

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Charité, Campus Virchow Klinikum

    Berlin, State of Berlin, 13353

  • GYNAEKOLOGICUM Bremen

    Bremen, Free Hanseatic City of Bremen, 28211

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Universität Erlangen-Nürnberg

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH

    Essen, North Rhine-Westphalia, 45136

  • Klinikum der J. W. Goethe-Universität

    Frankfurt am Main, Hesse, 60590

  • Klinikum Göttingen, Georg-August-Universität

    Göttingen, Lower Saxony, 37075

  • Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20251

  • Gynäkologisch-onkologische Praxis

    Hanover, Lower Saxony, 30177

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Gießen-Marburg, Standort Marburg

    Marburg, Hesse, 35043

  • Klinikum rechts der Isar der Technischen Universität

    München, Bavaria, 81675

  • Klinikum Offenbach

    Offenbach, Hesse, 63069

  • Städt. Klinikum Solingen gGmbH

    Solingen, North Rhine-Westphalia, 42653

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

About this study

Official title: Activity, Tolerability, Safety of Temsirolimus in Women With Ovarian Cancer Who Progressed During Previous Platinum Chemotherapy or Within 6 Months After Therapy or Advanced Endometrial Carcinoma

The purpose of this study is to determine the activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma.

Being tested
Temsirolimus
Keywords
Ovarian Cancer, Endometrial Carcinoma, Temsirolimus
Medical subject headings
Genital Diseases, Female, Ovarian Diseases, Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

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

  • TemsirolimusDrug

    25mg weekly intravenous until progression

Study groups in NCT01460979
Study groupRoleWhat they receive
TemsirolimusExperimentalNot described
Receives: Drug: Temsirolimus

What is being measured

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

  1. progression-free survival

    Measured: after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry

Secondary outcomes (6)

  1. rate and duration of stable diseases according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and Gynecologic Cancer Intergroup (GCIG)-criteria for ovarian cancer

    Measured: every 8 weeks until progression

  2. progression-free survival according to RECIST 1.1 and cancer antigen 125 (CA 125) (for ovarian cancer) (biological progression-free survival (PFSbio))

    Measured: every 8 weeks until progression

  3. overall survival

    Measured: weekly until progression; thereafter every 8 weeks

  4. safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions

    Measured: weekly until progression; thereafter every 8 weeks

  5. quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) questionaires "QLQ C30", "QLQ OV28" and "QLQ-EN24"

    Measured: every 8 weeks

  6. rate and duration of stable diseases according to RECIST-criteria for endometrial cancer

    Measured: every 8 weeks until progression

Timeline

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

  1. First posted27 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJun 2015
  4. Study completionNov 2015

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460979
Sponsor's protocol ID
AGO-GYN 8
Status last verified
Feb 2016
First submitted
25 Oct 2011
Last updated
29 Feb 2016
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 Genital Diseases, Female and Ovarian Diseases, run by AGO Study Group at 18 sites in Germany.

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 16 inclusion and 29 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: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

progression-free survival (time frame: after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry). 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 NCT01460979.

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 29 Feb 2016.

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