A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.

Study Overview
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Brief Summary
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The purpose of this study is to help answer the following research questions: If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events

Official Title
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A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no prior therapy for rectal cancer pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery. adequate organ function Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1 signed informed consent at least 18 years of age surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment. Exclusion Criteria: concurrent administration of any other anti-tumor therapy treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry serious concomitant systemic disorders previously completed or withdrawn from this study pregnant or breast-feeding second primary malignancy history of significant neurological or mental disorder, including seizures or dementia inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs) presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry inability or unwillingness to take folic acid, vitamin B12 or dexamethasone

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: A<br> | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 3 cycles<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Pemetrexed Prior to Surgery | Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed. | 3 cycles (21-day cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological Complete Response (pCR) | Pathological complete response was defined as the absence of any tumor cells. | surgery following 3 cycles (21-day cycles) of chemotherapy | 
| Number of Participants With Complete Tumor Resection |  | surgery following 3 cycles (21-day cycles) of chemotherapy | 
| Number of Participants Receiving Sphincter Saving Surgery |  | surgery following 3 cycles (21-day cycles) of chemotherapy |