Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal 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.
 
ClinicalTrials.gov Identifier: NCT00191984
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : June 15, 2009
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: pemetrexed
Drug: irinotecan
Enrollment 46
Recruitment Details  
Pre-assignment Details Two participants discontinued the trial before receiving study treatment. One due to entry criteria exclusion and one due to withdrawal by subject. Therefore, 44 participants received at least one dose of chemotherapy and are included in the efficacy and safety analyses.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Period Title: Overall Study
Started 46
Completed 7
Not Completed 39
Reason Not Completed
Disease Progression             21
Adverse Event             4
Death             2
Entry Criteria Exclusion             1
Withdrawal by Subject             7
Physician Decision             4
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
60.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
13
  29.5%
Male
31
  70.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 44 participants
44
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 44 participants
0 - Fully Active 24
1 - Ambulatory, Restricted Strenuous Activity 15
2 - Ambulatory, No Work Activities 5
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Pathological Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Adenocarcinoma of Colon 22
Adenocarcinoma of Rectum 20
Colorectal Cancer 2
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 44 participants
169.3  (8.5)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 44 participants
69.3  (11.7)
1.Primary Outcome
Title Best Overall Tumor Response
Hide Description

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.

Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.

Time Frame baseline to measured progressive disease (up to 2 years follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with at least one completed cycle.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description:
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
Partial Response 6
Stable Disease 18
Progressive Disease 15
Unknown 5
2.Secondary Outcome
Title Duration of Response
Hide Description

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.

Time Frame time of response to progressive disease or death (up to 2 years follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with at least completed cycle and who had a complete or partial response.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description:
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: days
236
(105 to 353)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.
Time Frame baseline to measured progressive disease or death (up to 2 years follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with at least one completed cycle.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description:
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: days
123
(60 to 146)
4.Secondary Outcome
Title Time to Treatment Failure
Hide Description Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time Frame baseline to stopping treatment (up to 2 years follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with at least one completed cycle.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description:
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: days
66
(55 to 105)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame baseline to date of death from any cause (up to 2 years follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with at least one completed cycle.
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description:
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: days
422
(305 to 602)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed + Irinotecan
Hide Arm/Group Description Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
All-Cause Mortality
Pemetrexed + Irinotecan
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Irinotecan
Affected / at Risk (%) # Events
Total   13    
Blood and lymphatic system disorders   
Anaemia  1  3/44 (6.82%)  3
Febrile neutropenia  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Diarrhoea  1  3/44 (6.82%)  4
Melaena  1  1/44 (2.27%)  1
Nausea  1  1/44 (2.27%)  1
Vomiting  1  2/44 (4.55%)  2
General disorders   
Asthenia  1  1/44 (2.27%)  1
General physical health deterioration  1  1/44 (2.27%)  1
Pyrexia  1  1/44 (2.27%)  1
Hepatobiliary disorders   
Hepatic pain  1  1/44 (2.27%)  1
Immune system disorders   
Hypersensitivity  1  1/44 (2.27%)  1
Infections and infestations   
Septic shock  1  1/44 (2.27%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/44 (4.55%)  2
Diabetes mellitus insulin-dependent  1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/44 (4.55%)  2
Hypoxia  1  1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/44 (2.27%)  1
Vascular disorders   
Hypertensive crisis  1  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed + Irinotecan
Affected / at Risk (%) # Events
Total   38    
Blood and lymphatic system disorders   
Anaemia  1  10/44 (22.73%)  11
Neutropenia  1  7/44 (15.91%)  11
Eye disorders   
Conjunctivitis  1  4/44 (9.09%)  5
Gastrointestinal disorders   
Abdominal pain  1  6/44 (13.64%)  10
Constipation  1  8/44 (18.18%)  10
Diarrhoea  1  15/44 (34.09%)  24
Nausea  1  18/44 (40.91%)  38
Vomiting  1  11/44 (25.00%)  24
General disorders   
Asthenia  1  24/44 (54.55%)  29
Mucosal inflammation  1  4/44 (9.09%)  10
Pyrexia  1  6/44 (13.64%)  12
Investigations   
Alanine aminotransferase increased  1  4/44 (9.09%)  5
Aspartate aminotransferase increased  1  3/44 (6.82%)  3
Weight decreased  1  9/44 (20.45%)  9
Weight increased  1  3/44 (6.82%)  3
Metabolism and nutrition disorders   
Anorexia  1  8/44 (18.18%)  9
Psychiatric disorders   
Anxiety  1  3/44 (6.82%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  3/44 (6.82%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191984    
Other Study ID Numbers: 8673
H3E-FP-S057 ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: April 27, 2009
Results First Posted: June 15, 2009
Last Update Posted: January 5, 2011