Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Condition: Relapsed Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Temsirolimus
Intervention description: Temsirolimus
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed bladder cancer

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.
    

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