Trial Outcomes & Findings for A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer (NCT NCT00191984)
NCT ID: NCT00191984
Last Updated: 2011-01-05
Results Overview
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.
COMPLETED
PHASE2
46 participants
baseline to measured progressive disease (up to 2 years follow-up)
2011-01-05
Participant Flow
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.
Participant milestones
| Measure |
Pemetrexed + Irinotecan
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 Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Pemetrexed + Irinotecan
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 Study
Disease Progression
|
21
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Entry Criteria Exclusion
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Irinotecan
n=44 Participants
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Age Continuous
|
60.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
44 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
24 units on a scale
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
15 units on a scale
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory, No Work Activities
|
5 units on a scale
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of Colon
|
22 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocarcinoma of Rectum
|
20 participants
n=5 Participants
|
|
Pathological Diagnosis
Colorectal Cancer
|
2 participants
n=5 Participants
|
|
Height
|
169.3 centimeters
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Weight
|
69.3 kilograms
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 2 years follow-up)Population: All enrolled participants with at least one completed cycle.
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.
Outcome measures
| Measure |
Pemetrexed + Irinotecan
n=44 Participants
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Best Overall Tumor Response
Partial Response
|
6 participants
|
|
Best Overall Tumor Response
Stable Disease
|
18 participants
|
|
Best Overall Tumor Response
Progressive Disease
|
15 participants
|
|
Best Overall Tumor Response
Unknown
|
5 participants
|
SECONDARY outcome
Timeframe: time of response to progressive disease or death (up to 2 years follow-up)Population: All enrolled participants with at least completed cycle and who had a complete or partial response.
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.
Outcome measures
| Measure |
Pemetrexed + Irinotecan
n=6 Participants
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Duration of Response
|
236 days
Interval 105.0 to 353.0
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death (up to 2 years follow-up)Population: All enrolled participants with at least one completed cycle.
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.
Outcome measures
| Measure |
Pemetrexed + Irinotecan
n=44 Participants
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Progression-Free Survival (PFS)
|
123 days
Interval 60.0 to 146.0
|
SECONDARY outcome
Timeframe: baseline to stopping treatment (up to 2 years follow-up)Population: All enrolled participants with at least one completed cycle.
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.
Outcome measures
| Measure |
Pemetrexed + Irinotecan
n=44 Participants
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Time to Treatment Failure
|
66 days
Interval 55.0 to 105.0
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (up to 2 years follow-up)Population: All enrolled participants with at least one completed cycle.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Pemetrexed + Irinotecan
n=44 Participants
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 Survival
|
422 days
Interval 305.0 to 602.0
|
Adverse Events
Pemetrexed + Irinotecan
Serious adverse events
| Measure |
Pemetrexed + Irinotecan
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
3/44 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
3/44 • Number of events 4
|
|
Gastrointestinal disorders
Melaena
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Asthenia
|
2.3%
1/44 • Number of events 1
|
|
General disorders
General physical health deterioration
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic pain
|
2.3%
1/44 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Septic shock
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Irinotecan
Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.7%
10/44 • Number of events 11
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.9%
7/44 • Number of events 11
|
|
Eye disorders
Conjunctivitis
|
9.1%
4/44 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
6/44 • Number of events 10
|
|
Gastrointestinal disorders
Constipation
|
18.2%
8/44 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
34.1%
15/44 • Number of events 24
|
|
Gastrointestinal disorders
Nausea
|
40.9%
18/44 • Number of events 38
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
11/44 • Number of events 24
|
|
General disorders
Asthenia
|
54.5%
24/44 • Number of events 29
|
|
General disorders
Mucosal inflammation
|
9.1%
4/44 • Number of events 10
|
|
General disorders
Pyrexia
|
13.6%
6/44 • Number of events 12
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
4/44 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Weight decreased
|
20.5%
9/44 • Number of events 9
|
|
Investigations
Weight increased
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
8/44 • Number of events 9
|
|
Psychiatric disorders
Anxiety
|
6.8%
3/44 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
3/44 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60