Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas

This study has been terminated.
(Original PI left institution and sponsor decided to end support.)
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00996346
First received: October 14, 2009
Last updated: August 2, 2015
Last verified: August 2015
Results First Received: June 6, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Interventions: Drug: Irinotecan&Temsirolimus:Arm1, Level 1
Drug: Irinotecan&Temsirolimus:Arm 1, Level 2
Drug: Irinotecan&Temsirolimus:Arm 2, Level 1

  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
Subjects were recruited between October, 2009, and May, 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Irinotecan&Temsirolimus:Arm 1, Level 1

Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

One cycle is four weeks.

Irinotecan&Temsirolimus:Arm 1, Level 2

Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

One cycle is four weeks.

Irinotecan&Temsirolimus:Arm 2, Level 1 Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

Participant Flow:   Overall Study
    Irinotecan&Temsirolimus:Arm 1, Level 1     Irinotecan&Temsirolimus:Arm 1, Level 2     Irinotecan&Temsirolimus:Arm 2, Level 1  
STARTED     6     8     3  
COMPLETED     6     8     3  
NOT COMPLETED     0     0     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.
No text entered.

Reporting Groups
  Description
Irinotecan&Temsirolimus:Arm 1, Level 1

Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

One cycle is four weeks.

Irinotecan&Temsirolimus:Arm 1, Level 2

Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

One cycle is four weeks.

Irinotecan&Temsirolimus:Arm 2, Level 1 Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
Total Total of all reporting groups

Baseline Measures
    Irinotecan&Temsirolimus:Arm 1, Level 1     Irinotecan&Temsirolimus:Arm 1, Level 2     Irinotecan&Temsirolimus:Arm 2, Level 1     Total  
Number of Participants  
[units: participants]
  6     8     3     17  
Age  
[units: years]
Median (Full Range)
  60.5   (48 to 69)     47.5   (25 to 72)     56   (56 to 64)     56   (25 to 72)  
Gender  
[units: participants]
       
Female     3     4     1     8  
Male     3     4     2     9  
Region of Enrollment  
[units: participants]
       
United States     6     8     3     17  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Irinotecan   [ Time Frame: Up to 1 month ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Temsirolimus   [ Time Frame: Up to 1 month ]


  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
No text entered.


  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: Monte Shaheen, MD / Study Principal Investigator
Organization: University of New Mexico Cancer Center
phone: 505-925-0404
e-mail: MoShaheen@salud.unm.edu


Publications of Results:

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00996346     History of Changes
Other Study ID Numbers: INST 0909, 3066K1, 3066K1-1208, 20091334, NCI-2011-01940
Study First Received: October 14, 2009
Results First Received: June 6, 2015
Last Updated: August 2, 2015
Health Authority: United States: Institutional Review Board