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

NCT01460979 | Completed Phase 2

• 1 other identifier: AGO-GYN 8
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 18

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

Genital Diseases, Female; Ovarian Diseases; Ovarian Neoplasms; Endometrial Neoplasms

Keywords

Ovarian Cancer; Endometrial Carcinoma; Temsirolimus

Outcome Measures

Primary Outcomes (1)

• progression-free survival

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

Secondary Outcomes (6)

• 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

  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))

  every 8 weeks until progression

• overall survival

  weekly until progression; thereafter every 8 weeks

• safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions

  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"

  every 8 weeks

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

25mg weekly intravenous until progression

Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AGO Study Group: lead

Study Sites (18)

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Universität Erlangen-Nürnberg

Erlangen, Bavaria, 91054, Germany

Location

Klinikum rechts der Isar der Technischen Universität

München, Bavaria, 81675, Germany

Location

GYNAEKOLOGICUM Bremen

Bremen, City state Bremen, 28211, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20251, Germany

Location

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Gießen-Marburg, Standort Marburg

Marburg, Hesse, 35043, Germany

Location

Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Klinikum Göttingen, Georg-August-Universität

Göttingen, Lower Saxony, 37075, Germany

Location

Gynäkologisch-onkologische Praxis

Hanover, Lower Saxony, 30177, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH

Essen, North Rhine-Westphalia, 45136, Germany

Location

Städt. Klinikum Solingen gGmbH

Solingen, North Rhine-Westphalia, 42653, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charité, Campus Virchow Klinikum

Berlin, State of Berlin, 13353, Germany

Location

Related Links

• Final publication

MeSH Terms

Conditions

Genital Diseases, Female; Ovarian Diseases; Ovarian Neoplasms; Endometrial Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Neoplasms; Uterine Diseases

Study Officials

• Günter Emons, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

DE (18)