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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT01460979
First received: October 25, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Genital Diseases, Female
Ovarian Diseases
Ovarian Neoplasms
Endometrial Neoplasms
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Tolerability and Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
  • progression-free survival according to RECIST 1.1 and cancer antigen 125 (CA 125) (for ovarian cancer) (biological progression-free survival (PFSbio)) [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: weekly until progression; thereafter every 8 weeks ] [ Designated as safety issue: No ]
  • safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions [ Time Frame: weekly until progression; thereafter every 8 weeks ] [ Designated as safety issue: Yes ]
  • quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) questionaires "QLQ C30", "QLQ OV28" and "QLQ-EN24" [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • rate and duration of stable diseases according to RECIST-criteria for endometrial cancer [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus Drug: Temsirolimus
25mg weekly intravenous until progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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
  • 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
  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: NCT01460979

Locations
Germany
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89075
Universität Erlangen-Nürnberg
Erlangen, Bayern, Germany, 91054
Klinikum rechts der Isar der Technischen Universität
München, Bayern, Germany, 81675
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Hessen, Germany, 60590
Universitätsklinikum Gießen-Marburg, Standort Marburg
Marburg, Hessen, Germany, 35043
Klinikum Offenbach
Offenbach, Hessen, Germany, 63069
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Greifswald, Mecklenburg Vorpommern, Germany, 17475
Klinikum Göttingen, Georg-August-Universität
Göttingen, Niedersachsen, Germany, 37075
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Gynäkologisch-onkologische Praxis
Hannover, Niedersachsen, Germany, 30177
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH
Essen, Nordrhein-Westfalen, Germany, 45136
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45122
Städt. Klinikum Solingen gGmbH
Solingen, Nordrhein-Westfalen, Germany, 42653
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Charité, Campus Virchow Klinikum
Berlin, Germany, 13353
GYNAEKOLOGICUM Bremen
Bremen, Germany, 28211
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Sponsors and Collaborators
AGO Study Group
Investigators
Study Chair: Günter Emons, Professor AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie)
  More Information

No publications provided

Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT01460979     History of Changes
Other Study ID Numbers: AGO-GYN 8
Study First Received: October 25, 2011
Last Updated: March 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AGO Study Group:
Ovarian Cancer
Endometrial Carcinoma
Temsirolimus

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

ClinicalTrials.gov processed this record on October 16, 2014