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Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed Bladder Cancer

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Trial Information

Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer


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.


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 France only : Patients affiliated to a social security
program

Exclusion Criteria:

- Presence of uncontrolled metastatic brain or meningeal tumours

- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the efficacy of Temsirolimus (Torisel ®) in terms of non-progression rate (PR+CR+SD) after 2 months of treatment

Outcome Description:

Evaluation of the efficacy of Temsirolimus (Torisel ®) in terms of non-progression rate (PR+CR+SD) after 2 months of treatment

Outcome Time Frame:

12/2013 (2 months)

Safety Issue:

No

Principal Investigator

Nadine HOUEDE, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2009-08

NCT ID:

NCT01827943

Start Date:

June 2009

Completion Date:

December 2016

Related Keywords:

  • Relapsed Bladder Cancer
  • Relapsed bladder cancer
  • Urinary Bladder Neoplasms

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