Study of Pemetrexed for Second-Line Pancreas Cancer

Phase 2

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
chemotherapy	pemetrexed	pemetrexed

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	6 months after last patient enrolled	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response	Within two months of the completion of the last dose of chemotherapy	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
Number of Participants With Adverse Events	30 days after last dose of study drug	Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
CA 19-9 Response	Within two months of the last dose of chemotherapy	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.