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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Bergonié
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus

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