Sirolimus in Treating Patients With Advanced Pancreatic 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. Identifier: NCT00499486
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Drug: sirolimus

  Participant Flow

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
During baseline evaluation (approximately 72 hours prior to treatment with rapamycin), patients will receive a single dose of 3 mg oral midazolam as phenotypic evaluation of CYP3A4 activity.

Reporting Groups
Sirolimus Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.

Participant Flow:   Overall Study
Withdrawal by Subject                16 

  Baseline Characteristics

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.
All patients had previously progressed to a gemcitabine-containing regimen, including 22 patients who had received previous chemotherapy for metastatic disease.

Reporting Groups
Sirolimus adencarcinoma refractory to gemcitibine

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   22 
[Units: Participants]
Female   15 
Male   32 
Region of Enrollment 
[Units: Participants]
United States   47 

  Outcome Measures

1.  Primary:   Percentage of Patients With Overall Survival at 6 Months   [ Time Frame: 6- month survival rate (6mSR) ]

2.  Primary:   Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST   [ Time Frame: response at 2 and 6 months ]

3.  Primary:   Severity of Adverse Events as Assessed by NCI CTCAE v3.0   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Hidalgo
Organization: The Sidney Kimmel Comprehensive Cancer Centre at Johns Hopkins

Publications of Results:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00499486     History of Changes
Other Study ID Numbers: JHOC-J0415, CDR0000549899
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: March 18, 2013
Results First Posted: October 19, 2016
Last Update Posted: October 19, 2016