## Protocol Section
### Identification Module
**NCT ID:** NCT01460979

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

**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

#### Organization Study ID Info
**ID:** AGO-GYN 8
#### Organization
**Class:** OTHER
**Full Name:** AGO Study Group
### Status Module
#### Completion Date
**Date:** 2015-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-02-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-02-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Start Date
**Date:** 2011-10

**Status Verified Date:** 2016-02

#### Study First Post Date
**Date:** 2011-10-27
**Type:** ESTIMATED
**Study First Submit Date:** 2011-10-25
**Study First Submit QC Date:** 2011-10-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** AGO Study Group

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Genital Diseases, Female

- Ovarian Diseases

- Ovarian Neoplasms

- Endometrial Neoplasms

**Keywords:**

- Ovarian Cancer

- Endometrial Carcinoma

- Temsirolimus

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 47

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Temsirolimus

**Label:** Temsirolimus

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Temsirolimus

**Description:** 25mg weekly intravenous until progression

**Name:** Temsirolimus

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** progression-free survival

**Time Frame:** after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry

#### Secondary Outcomes

**Measure:** 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

**Measure:** 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

**Measure:** overall survival

**Time Frame:** weekly until progression; thereafter every 8 weeks

**Measure:** safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions

**Time Frame:** weekly until progression; thereafter every 8 weeks

**Measure:** 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

**Measure:** rate and duration of stable diseases according to RECIST-criteria for endometrial cancer

**Time Frame:** every 8 weeks until progression

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ulm

**Country:** Germany

**Facility:** Universitätsklinikum Ulm

**State:** Baden-Württemberg

**Zip:** 89075

**Location 2:**

**City:** Erlangen

**Country:** Germany

**Facility:** Universität Erlangen-Nürnberg

**State:** Bayern

**Zip:** 91054

**Location 3:**

**City:** München

**Country:** Germany

**Facility:** Klinikum rechts der Isar der Technischen Universität

**State:** Bayern

**Zip:** 81675

**Location 4:**

**City:** Frankfurt am Main

**Country:** Germany

**Facility:** Klinikum der J. W. Goethe-Universität

**State:** Hessen

**Zip:** 60590

**Location 5:**

**City:** Marburg

**Country:** Germany

**Facility:** Universitätsklinikum Gießen-Marburg, Standort Marburg

**State:** Hessen

**Zip:** 35043

**Location 6:**

**City:** Offenbach

**Country:** Germany

**Facility:** Klinikum Offenbach

**State:** Hessen

**Zip:** 63069

**Location 7:**

**City:** Greifswald

**Country:** Germany

**Facility:** Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität

**State:** Mecklenburg Vorpommern

**Zip:** 17475

**Location 8:**

**City:** Göttingen

**Country:** Germany

**Facility:** Klinikum Göttingen, Georg-August-Universität

**State:** Niedersachsen

**Zip:** 37075

**Location 9:**

**City:** Hannover

**Country:** Germany

**Facility:** Gynäkologisch-onkologische Praxis

**State:** Niedersachsen

**Zip:** 30177

**Location 10:**

**City:** Hannover

**Country:** Germany

**Facility:** Medizinische Hochschule Hannover

**State:** Niedersachsen

**Zip:** 30625

**Location 11:**

**City:** Essen

**Country:** Germany

**Facility:** Universitätsklinikum Essen

**State:** Nordrhein-Westfalen

**Zip:** 45122

**Location 12:**

**City:** Essen

**Country:** Germany

**Facility:** Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH

**State:** Nordrhein-Westfalen

**Zip:** 45136

**Location 13:**

**City:** Solingen

**Country:** Germany

**Facility:** Städt. Klinikum Solingen gGmbH

**State:** Nordrhein-Westfalen

**Zip:** 42653

**Location 14:**

**City:** Dresden

**Country:** Germany

**Facility:** Universitätsklinikum Carl Gustav Carus

**State:** Sachsen

**Zip:** 01307

**Location 15:**

**City:** Kiel

**Country:** Germany

**Facility:** Universitätsklinikum Schleswig-Holstein, Campus Kiel

**State:** Schleswig-Holstein

**Zip:** 24105

**Location 16:**

**City:** Berlin

**Country:** Germany

**Facility:** Charité, Campus Virchow Klinikum

**Zip:** 13353

**Location 17:**

**City:** Bremen

**Country:** Germany

**Facility:** GYNAEKOLOGICUM Bremen

**Zip:** 28211

**Location 18:**

**City:** Hamburg

**Country:** Germany

**Facility:** Universitätsklinikum Hamburg-Eppendorf

**Zip:** 20251

#### Overall Officials

**Official 1:**

**Affiliation:** AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie)

**Name:** Günter Emons, Professor

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** Final publication

**URL:** http://www.ncbi.nlm.nih.gov/pubmed/26731724

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000014591

- Term: Uterine Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: HIGH

- As Found: Genital Diseases, Female

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Carcinoma

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Neoplasms

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: HIGH

- As Found: Genital Diseases

- ID: M12972

- Name: Ovarian Diseases

- Relevance: HIGH

- As Found: Ovarian Diseases

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000009369

- Term: Neoplasms

- ID: D000016889

- Term: Endometrial Neoplasms

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000005831

- Term: Genital Diseases, Female

### Intervention Browse Module - Ancestors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000935

- Term: Antifungal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21960

- Name: Sirolimus

- Relevance: HIGH

- As Found: Average

- ID: M353695

- Name: Temsirolimus

- Relevance: HIGH

- As Found: Average

- ID: M2827

- Name: MTOR Inhibitors

- Relevance: HIGH

- As Found: Average

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020123

- Term: Sirolimus

- ID: C000401859

- Term: Temsirolimus

- ID: D000091203

- Term: MTOR Inhibitors

### Misc Info Module

- Version Holder: 2024-05-24
