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

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Relapsed Bladder Cancer

Treatments: Drug: Temsirolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01827943

IB2009-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Temsirolimus

Experimental group

Description:

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.

Treatment:

Drug: Temsirolimus