Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer

Study Overview
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Brief Summary
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In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan. The purposes of this study are to determine: How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy. The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan. Whether pemetrexed can help patients with colorectal cancer.

Official Title
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A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have: Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum. Performance status of 0 to 2 on the ECOG Performance Status Scale. Standard postoperative adjuvant radiation therapy for rectal cancer is allowed. Locally advanced or metastatic disease. Must be 18 years of age. Exclusion Criteria: The patient must not have: Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment. Received prior treatment with irinotecan in the adjuvant setting. Are unable to take vitamin B12 or folic acid. Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period. Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.

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: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives of the study are as follows: |  |  | 
| to assess the following time to event efficacy endpoints for patients in both treatment arms: |  |  | 
| overall survival |  |  | 
| progression free survival |  |  | 
| duration of response |  |  | 
| to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population |  |  |