platinum-refractory ovarian carcinoma or advanced endometrial carcinoma MedDRA version: 15.1 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TORISEL (R)
Product Name: TORISEL
Pharmaceutical Form: Concentrate and diluent for solution for infusion
Sponsors
AGO Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *women = 18 years *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 taxan-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 (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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *ECOG > 2 *prior therapy with 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 ULN) *inadequate liver function (AST, ALT, GGT >2.5 x ULN or >5.0 x ULN in the presence of liver metastasis; Bilirubin >1.5 x ULN) *platelets 150/100 mmHg despite optimal medicinal treatment) *current cardiac arrhythmias (NCI CTCAE grade =2), atrial fibrillation, prolongation of QTc >470 msec *left ventricular ejection fraction (LVEF) =50% defined by ECHO *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 *HIV positive or manifested 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression-free survival rate after 4 months (recurrent ovarian cancer) or 6 months (endometrial cancer);Secondary Objective: -rate and duration of stable diseases according to RECIST 1.1 and GCIG-criteria for ovarian cancer and RECIST-criteria for endometrial cancer -progression-free survival according to RECIST 1.1 and CA 125 (for ovarian cancer) (PFSbio) -overall survival -safety and toxicity according to “Common Toxicity Criteria for Adverse Events” (CTCAE), Version 4.0 -quality of life according to EORTC QLQ C30, QLQ OV28 and QLQ-EN24;Primary end point(s): Ovarian Cancer: after 16 weeks under treatment with Temsirolimus the probability of progression free survival must have a minimum of 40% Endometrial Cancer: after 24 weeks under treatment with Temsirolimus the probability of progression free survival must have a minimum of 40%;Timepoint(s) of evaluation of this end point: Ovarian Cancer: 16 weeks after start of treatment of the last patient Endometrial Cancer: 24 weeks after start of treatment of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate and duration of disease stabilization Progression-free survival according to RECIST 1.1 and CA 125 (PFSbio) Overall survival Safety and toxicity profile Quality of Life ;Timepoint(s) of evaluation of this end point: Intervals are every 8 weeks until disease progression | — |
Countries
Germany
Contacts
Public ContactStudy Office
AGO Research GmbH
Outcome results
None listed