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Trial record 2 of 16 for:    11784875 [PUBMED-IDS]

Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00923273
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : October 23, 2013
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: FDG-PET
Drug: Pemetrexed
Drug: Sirolimus
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic acid tablets
Drug: Dexamethasone tablets

  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
DL5 wasn’t tolerated. We expanded DL4, had 1 DLT of gr. 3 infection that was possibly related to study drugs or his cancer and declining health. The last subject on DL4 had gr. 4 neutropenia that lasted <7days. We believe this wasn’t significant and a lack of foresight to add length of neutropenia as DLT. IRB allowed DL4 with DLT stopping rule.

Reporting Groups
  Description
Treatment Level 1: 3mg Load Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
Treatment Level 2: 6mg Load Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
Treatment Level 3: 6mg Load Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
Treatment Level 4: 10mg Load Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
Treatment Level 5: 15mg Load Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2

Participant Flow for 2 periods

Period 1:   Phase I Treatment Period
    Treatment Level 1: 3mg Load   Treatment Level 2: 6mg Load   Treatment Level 3: 6mg Load   Treatment Level 4: 10mg Load   Treatment Level 5: 15mg Load
STARTED   4 [1]   3 [2]   3 [2]   7 [3]   5 [4] 
COMPLETED   4   3   3   7   5 
NOT COMPLETED   0   0   0   0   0 
[1] The phase I portion will establish the maximum tolerated dose. 4 subjects peme naive.
[2] 3 subjects peme naive.
[3] 3 subjects initially enrolled and 4 subjects added after dose level 5; peme naive.
[4] 5 subjects peme naive.

Period 2:   Phase II Treatment Period
    Treatment Level 1: 3mg Load   Treatment Level 2: 6mg Load   Treatment Level 3: 6mg Load   Treatment Level 4: 10mg Load   Treatment Level 5: 15mg Load
STARTED   0 [1]   0   0   27 [2]   0 
COMPLETED   0   0   0   20   0 
NOT COMPLETED   0   0   0   7   0 
NE-brain mets/met disease prior enrollmt                0                0                0                1                0 
NE-not complete 2Cy trmt/no imaging done                0                0                0                6                0 
[1] The phase II portion will utilize the MTD from the phase I portion.
[2] Includes 8 subjects with prior peme;12 subjects who were peme naive; 7 subjects rolled over from phI



  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.
No text entered.

Reporting Groups
  Description
Treatment Level 1: 3mg Load Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
Treatment Level 2: 6mg Load Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
Treatment Level 3: 6mg Load Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
Treatment Level 4: 10 mg Load Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
Treatment Level 5: 15mg Load Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
Total Total of all reporting groups

Baseline Measures
   Treatment Level 1: 3mg Load   Treatment Level 2: 6mg Load   Treatment Level 3: 6mg Load   Treatment Level 4: 10 mg Load   Treatment Level 5: 15mg Load   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   3   3   27   5   42 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   2   0   1   18   4   25 
>=65 years   2   3   2   9   1   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.65  (7.84)   71.57  (3.76)   61.7  (24.74)   59.5  (11.48)   56.08  (10.75)   60.6  (11.99) 
Gender 
[Units: Participants]
           
Female   2   2   1   14   2   21 
Male   2   1   2   13   3   21 
Ethnicity (NIH/OMB) 
[Units: Participants]
           
Hispanic or Latino   0   1   1   2   0   4 
Not Hispanic or Latino   4   2   2   25   5   38 
Unknown or Not Reported   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   1   1   4   0   6 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   0   1   1   4   0   6 
White   4   0   1   18   5   28 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   0   1   0   1   0   2 
Region of Enrollment 
[Units: Participants]
           
United States   4   3   3   27   5   42 


  Outcome Measures

1.  Primary:   Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed   [ Time Frame: 5 weeks ]

2.  Primary:   Phase II: Clinical Response Rate   [ Time Frame: 21 weeks ]

3.  Primary:   Phase I: Maximum Tolerated Dose (MTD) of Sirolimus   [ Time Frame: 5 weeks ]

4.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 45 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:  
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. Arun Rajan
Organization: National Cancer Institute
phone: 301-594-5322
e-mail: rajana@mail.nih.gov


Publications:

Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923273     History of Changes
Obsolete Identifiers: NCT00636532
Other Study ID Numbers: 080078
08-C-0078
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: May 24, 2013
Results First Posted: October 23, 2013
Last Update Posted: October 2, 2015