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

Phase 2
18 Years
Open (Enrolling)
Genital Diseases, Female, Ovarian Diseases, Ovarian Neoplasms, Endometrial Neoplasms

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Trial Information

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

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

- 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

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

- 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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Günter Emons, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie)


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2011

Completion Date:

October 2015

Related Keywords:

  • Genital Diseases, Female
  • Ovarian Diseases
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Ovarian Cancer
  • Endometrial Carcinoma
  • Temsirolimus
  • Neoplasms
  • Carcinoma
  • Endometrial Neoplasms
  • Genital Diseases, Female
  • Ovarian Neoplasms
  • Ovarian Diseases
  • Adenoma