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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01938573
First Posted: September 10, 2013
Last Update Posted: October 20, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington
Results First Submitted: August 18, 2017  
Study Type: Interventional
Study Design: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phase 2

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

Phase I Sirolimus 35 mg PO day -2, cisplatin 70 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1 and 8, every 21 days

Participant Flow:   Overall Study
    Phase 2   Phase I
STARTED   15   6 
COMPLETED   13   6 
NOT COMPLETED   2   0 
Lack of Efficacy                1                0 
Operation at other hospital                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients with either metastatic (phase 1) or localized (phase 2) bladder cancer

Reporting Groups
  Description
Sirolimus, Cisplatin, Gemcitabine

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


Baseline Measures
   Sirolimus, Cisplatin, Gemcitabine 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 21 
   69 
 (51 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 21 
Female      1   4.8% 
Male      20  95.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 21 
United States   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patients With Dose Limiting Toxicity   [ Time Frame: Up to 28 days ]

2.  Primary:   Percent of Patients With Pathologic Complete Response (Phase II)   [ Time Frame: 12 weeks ]

3.  Secondary:   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)   [ Time Frame: Up to 28 days after completion of study treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Bruce Montgomery
Organization: University of Washington
phone: 206-598-0860
e-mail: rbmontgo@uw.edu



Responsible Party: Bruce Montgomery, University of Washington
ClinicalTrials.gov Identifier: NCT01938573     History of Changes
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