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Study of Pemetrexed for Second-Line Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT00864513
Recruitment Status : Terminated (At interim analysis the study did not meet the response criteria to continue)
First Posted : March 18, 2009
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Hwang, Georgetown University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreas Cancer
Intervention Drug: pemetrexed
Enrollment 17
Recruitment Details From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.
Pre-assignment Details  
Arm/Group Title Chemotherapy
Hide Arm/Group Description Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Chemotherapy
Hide Arm/Group Description pemetrexed
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
55  (30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Progression-free Survival
Hide Description Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.
Time Frame 6 months after last patient enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
pemetrexed
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: days
59
(26 to 241)
2.Secondary Outcome
Title Objective Response
Hide Description Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0
Time Frame Within two months of the completion of the last dose of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
pemetrexed
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title CA 19-9 Response
Hide Description CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.
Time Frame Within two months of the last dose of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
pemetrexed
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
2
4.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Time Frame 30 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
pemetrexed
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy
Hide Arm/Group Description pemetrexed
All-Cause Mortality
Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Blood and lymphatic system disorders   
neutropenia   2/15 (13.33%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Chemotherapy
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
study was closed at interim analysis so only 12 subjects were evaluable for response, 15 subjects received treatment and were evaluable for adverse events
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jimmy Hwang
Organization: Georgetown University
Phone: 202-444-2198
EMail: jh96@gunet.georgetown.edu
Layout table for additonal information
Responsible Party: Jimmy Hwang, Georgetown University
ClinicalTrials.gov Identifier: NCT00864513     History of Changes
Other Study ID Numbers: IIT2007022
2007-022
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: March 24, 2011
Results First Posted: December 8, 2015
Last Update Posted: December 8, 2015