Clinical trial NCT01827943: Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Official title: Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed Bladder Cancer
Keywords: Relapsed bladder cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2013-04-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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. This study will also search for genes involved in the response to treatment.

Eligibility criteria: Inclusion Criteria:

* 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)
* Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.
* 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.
* France only : Patients affiliated to a social security program

Exclusion Criteria:

* Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
* Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion
* 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

Primary outcomes:
measure: Non-progression Rate at 2 Months
timeFrame: 2 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)
measure: Progression-free Survival
timeFrame: Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Hôpital d'instruction des armées du Val-de-Grâce
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Institut Bergonié
name: Nadine HOUEDE, MD
role: STUDY_CHAIR
References:
citation: 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.