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

Primary Purpose

Relapsed Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Temsirolimus
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Bladder Cancer focused on measuring Relapsed bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Bordeaux
  • Centre François Baclesse
  • Centre Jean Perrin
  • CHU Henri Mondor
  • Centre Léon Bérard
  • Hôpital d'instruction des armées du Val-de-Grâce
  • CHU de Rouen
  • Institut Claudius Regaud
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temsirolimus

Arm 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.

Outcomes

Primary Outcome Measures

Non-progression Rate at 2 Months
Non-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.

Secondary Outcome Measures

Overall Survival
OS was was defined as the time from the treatment initiation to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Progression-free Survival
Progression-free survival (PFS) was defined as the time from the initiation of treatment to the first documented progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Patients alive and progression free were censored at the date of last follow-up or last patient contact. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.

Full Information

First Posted
October 29, 2012
Last Updated
April 9, 2021
Sponsor
Institut Bergonié
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01827943
Brief Title
Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Acronym
VESTOR
Official Title
Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Bladder Cancer
Keywords
Relapsed bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temsirolimus
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Other Intervention Name(s)
Torisel
Intervention Description
Temsirolimus
Primary Outcome Measure Information:
Title
Non-progression Rate at 2 Months
Description
Non-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS was was defined as the time from the treatment initiation to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Time Frame
Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)
Title
Progression-free Survival
Description
Progression-free survival (PFS) was defined as the time from the initiation of treatment to the first documented progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Patients alive and progression free were censored at the date of last follow-up or last patient contact. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Time Frame
Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine HOUEDE, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital d'instruction des armées du Val-de-Grâce
City
Paris
ZIP/Postal Code
75230
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29454321
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.
Results Reference
result

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

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