A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

Official Title
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Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy. Patient must have at least one unidimensionally measurable lesion. Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment. Performance status 0 to 2 Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease Exclusion Criteria: Treatment with any drug within the last 30 days that has not received regulatory approval. Serious systemic disorder (cardiac or pulmonary disease, active infection) Documented brain metastases not amenable to surgery or unstable after radiation Inability or unwillingness to take folic acid or Vitamin B12 supplementation. Presence of fluid retention that can not be controlled by drainage.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed + Irinotecan<br> | Drug: pemetrexed<br>* 400 mg/m^2, intravenous (IV), every 14 days x 12 cycles<br>* Other names: Alimta;Drug: irinotecan<br>* 180 mg/m^2, intravenous (IV), every 14 days x 12 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Tumor Response | 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. | baseline to measured progressive disease (up to 2 years follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of 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. | time of response to progressive disease or death (up to 2 years follow-up) | 
| Progression-Free Survival (PFS) | 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. | baseline to measured progressive disease or death (up to 2 years follow-up) | 
| Time to Treatment Failure | 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. | baseline to stopping treatment (up to 2 years follow-up) | 
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline to date of death from any cause (up to 2 years follow-up) |