Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer

NCT01827943 | Completed Phase 2 Results

• 1 other identifier: IB2009-08
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 9

Brief Summary

In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.

Conditions

Relapsed Bladder Cancer

Keywords

Relapsed bladder cancer

Outcome Measures

Primary Outcomes (1)

• Non-progression Rate at 2 Months

  Non-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.

  2 months

Secondary Outcomes (2)

• Overall Survival

  Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)

• Progression-free Survival

  Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

Temsirolimus

Also known as: Torisel

Temsirolimus

Eligibility Criteria

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

You may qualify if:

• Men or women of at least 18 years of age
• Histologically proven Bladder cancer
• Locally advanced or metastatic disease (stage IV)
• Functional status (ECOG / OMS) ≤ 2
• Relapse after first-line chemotherapy
• Measurable lesions (RECIST criteria)
• Biological levels :
• Neutrophil count \>1,5.109/L.
• Platelets \>100.109/L
• Total serum bilirubin \< 1.5 × ULN
• Clearance of créatinine 40 ml/mm
• If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN
• With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 × ULN
• Signed informed consent
• Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.

You may not qualify if:

• Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
• Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or polysorbate 80 or to their excipients
• Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma curatively treated) or incidental (≤ pT2) prostate cancer found on a radical cystoprostatectomy material
• The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on the 30th day ( or at least 7 halves-lives, according to the shortest duration) before the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be purposely excluded.
• Auto-immune pathology, psychiatric or neurological disorder
• Any unstable medical condition
• Unstable cardiac disease
• Severe renal failure
• Unstable diabetes
• Pregnancy
• Patient enrolled in another therapeutic clinical trial
• Patient unable to follow and comply with the study procedures because of any geographical, social or medical condition
• Patient partially or totally deprived of his civil rights

Sponsors & Collaborators

• Institut Bergonié: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (9)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital d'instruction des armées du Val-de-Grâce

Paris, 75230, France

Location

CHU de Rouen

Rouen, 76031, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

• Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houede N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5.

  PMID: 29454321 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr Nadine Houede, oncologist
• Organization: Institut Bergonie

nadine.HOUEDE@chu-nimes.fr

05.56.33.33.33

Study Officials

• Nadine HOUEDE, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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 29, 2012
• First Posted: April 10, 2013
• Study Start: June 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 6, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-04

Locations

FR (9)