Study of Pemetrexed for Second-Line Pancreas Cancer

Study Overview
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Brief Summary
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This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine. In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.

Detailed Description
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This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.

Official Title
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A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the pancreas Prior treatment for distant or locally advanced disease with gemcitabine-based therapy Measurable or evaluable disease ECOG performance status 0-2 Adequate hematological parameters Adequate baseline liver function At least 28 days from any major surgery At least 2 weeks from the last radiation treatment Must have recovered from reversible toxicities of prior chemotherapy Must be able to discontinue any nonsteroidal anti-inflammatory medications Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements Exclusion Criteria: Any prior treatment with pemetrexed More than one prior chemotherapy regimen HIV positive on antiretroviral therapy Pregnant or lactating Prior organ allograft On concurrent antitumor therapy including radiation therapy or other chemotherapies Creatinine clearance 45 ml/min or less Absolute neutrophil count < 1500 Platelets < 75,000 Bilirubin > 1.5 times the upper limit of normal Transaminases > 3 times the upper limit of normal except in known liver metastasis wherein they may be </= 5 times upper limit of normal Clinically significant ascites or pleural effusion that cannot be drained Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

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: chemotherapy<br>pemetrexed | Drug: pemetrexed<br>* pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles<br>* Other names: NSC# 698037;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death. | 6 months after last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response | Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0 | Within two months of the completion of the last dose of chemotherapy | 
| CA 19-9 Response | CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline. | Within two months of the last dose of chemotherapy | 
| Number of Participants With Adverse Events | Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0 | 30 days after last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas, metastatic, recurrent