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Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938573
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Bladder Carcinoma
Stage II Bladder Cancer
Stage III Bladder Cancer
Stage IV Bladder Cancer
Interventions Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Drug: Sirolimus
Procedure: Cystectomy
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 2 Phase I
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Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

Sirolimus 35 mg PO day -2, cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1 and 8, every 21 days
Period Title: Overall Study
Started 15 6
Completed 13 6
Not Completed 2 0
Reason Not Completed
Lack of Efficacy             1             0
Operation at other hospital             1             0
Arm/Group Title Sirolimus, Cisplatin, Gemcitabine
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Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
Patients with either metastatic (phase 1) or localized (phase 2) bladder cancer
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
69
(51 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
1
   4.8%
Male
20
  95.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Patients With Dose Limiting Toxicity
Hide Description Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).
Time Frame Up to 28 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 - Sirolimus, Cisplatin, Gemcitabine
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Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Percent of Patients With Pathologic Complete Response (Phase II)
Hide Description The study will follow an optimal two-stage Simon design based on pathologic complete response rate.
Time Frame 12 weeks
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Hide Analysis Population Description
Patients treated in phase 2
Arm/Group Title Sirolimus, Cisplatin, Gemcitabine
Hide Arm/Group Description:

Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
4
  26.7%
3.Secondary Outcome
Title Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)
Hide Description Graded according to the NCI CTCAE version 4.0. Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). All adverse events resulting in discontinuation, dose modification, dosing interruption, and/or treatment delay of study drug will also be listed and tabulated by preferred term.
Time Frame Up to 28 days after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sirolimus, Cisplatin, Gemcitabine
Hide Arm/Group Description:

Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Number of events
45
Time Frame 4 months (neoadjuvant therapy (3 months) and 1 month after completion)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sirolimus, Cisplatin, Gemcitabine
Hide Arm/Group Description

Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)

Cisplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Sirolimus: Given PO

Cystectomy: Undergo cystectomy when appropriate

All-Cause Mortality
Sirolimus, Cisplatin, Gemcitabine
Affected / at Risk (%)
Total   0/21 (0.00%)    
Hide Serious Adverse Events
Sirolimus, Cisplatin, Gemcitabine
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sirolimus, Cisplatin, Gemcitabine
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  5/21 (23.81%)  5
Thrombocytopenia   8/21 (38.10%)  8
Anemia  4/21 (19.05%)  4
General disorders   
Fatigue  10/21 (47.62%)  10
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bruce Montgomery
Organization: University of Washington
Phone: 206-598-0860
EMail: rbmontgo@uw.edu
Layout table for additonal information
Responsible Party: Bruce Montgomery, University of Washington
ClinicalTrials.gov Identifier: NCT01938573    
Other Study ID Numbers: 8027
NCI-2013-01614 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8027 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: September 4, 2013
First Posted: September 10, 2013
Results First Submitted: August 18, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017