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

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE October 27, 2011
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
progression-free survival [ Time Frame: after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • 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 ]
  • 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 ]
  • overall survival [ Time Frame: weekly until progression; thereafter every 8 weeks ]
  • safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions [ Time Frame: weekly until progression; thereafter every 8 weeks ]
  • 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 ]
  • rate and duration of stable diseases according to RECIST-criteria for endometrial cancer [ Time Frame: every 8 weeks until progression ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Genital Diseases, Female
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Endometrial Neoplasms
Intervention  ICMJE Drug: Temsirolimus
25mg weekly intravenous until progression
Study Arms  ICMJE Experimental: Temsirolimus
Intervention: Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
86
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460979
Other Study ID Numbers  ICMJE AGO-GYN 8
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AGO Study Group
Study Sponsor  ICMJE AGO Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Günter Emons, Professor AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie)
PRS Account AGO Study Group
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP