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

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: NCT01460979
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : February 29, 2016
Information provided by (Responsible Party):
AGO Study Group

Brief 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.

Condition or disease Intervention/treatment Phase
Genital Diseases, Female Ovarian Diseases Ovarian Neoplasms Endometrial Neoplasms Drug: Temsirolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Temsirolimus Drug: Temsirolimus
25mg weekly intravenous until progression

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry ]

Secondary Outcome Measures :
  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 [ Time Frame: 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)) [ Time Frame: every 8 weeks until progression ]
  3. overall survival [ Time Frame: weekly until progression; thereafter every 8 weeks ]
  4. safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions [ Time Frame: 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" [ Time Frame: every 8 weeks ]
  6. rate and duration of stable diseases according to RECIST-criteria for endometrial cancer [ Time Frame: every 8 weeks until progression ]

Information from the National Library of Medicine

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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:

  • 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

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): NCT01460979

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Sponsors and Collaborators
AGO Study Group
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Study Chair: Günter Emons, Professor AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie)
Additional Information:
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Responsible Party: AGO Study Group Identifier: NCT01460979    
Other Study ID Numbers: AGO-GYN 8
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016
Keywords provided by AGO Study Group:
Ovarian Cancer
Endometrial Carcinoma
Additional relevant MeSH terms:
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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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs