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Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer

This study has been terminated.
(Withdrawal of funding from sponsor)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00921310
First received: June 15, 2009
Last updated: October 19, 2016
Last verified: October 2016
Results First Received: August 10, 2016  
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: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Pemetrexed
Drug: Temsirolimus

  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
The study opened to participant enrollment on 09/28/2009 and closed to participant enrollment on 12/20/2011.

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
Phase I Dose Level 1 (Pemetrexed & Temsirolimus)
  • Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle
  • Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Phase I Dose Level -1 (Pemetrexed & Temsirolimus)
  • Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
  • Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
Phase 2 (Pemetrexed & Temsirolimus)
  • Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
  • Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle
  • Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle

Participant Flow:   Overall Study
    Phase I Dose Level 1 (Pemetrexed & Temsirolimus)   Phase I Dose Level -1 (Pemetrexed & Temsirolimus)   Phase 2 (Pemetrexed & Temsirolimus)
STARTED   2   6   4 
COMPLETED   2   6   4 
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
Phase I (Premetrexed & Temsirolimus)
  • Participants enrolled in the Phase I portion Dose Level 1 received:

    • Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle
    • Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
  • Participants enrolled in the Phase I portion Dose Level -1 received:

    • Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle
    • Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
Phase 2 (Pemetrexed & Temsirolimus)

-Participants enrolled in the Phase 2 portion received:

  • Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle
  • Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
Total Total of all reporting groups

Baseline Measures
   Phase I (Premetrexed & Temsirolimus)   Phase 2 (Pemetrexed & Temsirolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   4   12 
Age 
[Units: Years]
Median (Full Range)
 58.5 
 (49 to 76) 
 67.5 
 (62 to 70) 
 62.5 
 (49 to 76) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   6   2   8 
Region of Enrollment 
[Units: Participants]
     
United States   8   4   12 


  Outcome Measures
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1.  Primary:   Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus   [ Time Frame: Completion of first cycle by all enrolled patients in Phase I portion of study ]

2.  Primary:   Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed   [ Time Frame: Completion of first cycle by all enrolled patients in Phase I portion of study ]

3.  Primary:   Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed   [ Time Frame: Completion of first cycle (approximately 21 days) ]

4.  Primary:   Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)   [ Time Frame: 2 years ]

5.  Primary:   Phase I Only: Phospho-Akt Levels in Circulating Mononuclear Cells   [ Time Frame: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8 ]

6.  Primary:   Phase I Only: Phospho-S6 Levels in Circulating Mononuclear Cells   [ Time Frame: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8 ]

7.  Secondary:   Phase 2 Only: Progression-free Survival (PFS)   [ Time Frame: 2 years from completion of treatment ]

8.  Secondary:   Phase 2 Only: Survival Rate   [ Time Frame: 1 year after start of treatment ]

9.  Secondary:   Phase 2 Only: Phospho-Akt Levels in Circulating Mononuclear Cells   [ Time Frame: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8 ]

10.  Secondary:   Phase 2 Only: Phospho-S6 Levels in Circulating Mononuclear Cells Before and After Treatment   [ Time Frame: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8 ]


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


Results Point of Contact:  
Name/Title: Maria Baggstrom, M.D.
Organization: Washington University School of Medicine
phone: 314-362-5737
e-mail: mbaggstr@dom.wustl.edu


Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00921310     History of Changes
Other Study ID Numbers: 09-0668 / 201105207
Study First Received: June 15, 2009
Results First Received: August 10, 2016
Last Updated: October 19, 2016
Health Authority: United States: Institutional Review Board