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Updated: Oct 17, 2026
Percutaneous Hepatic Perfusion (PHP) with Melphalan as a Treatment for Unresectable Metastases Confined to the Liver
Published on: July 31, 2016
Phase II study of the multitargeted antifolate LY231514 (ALIMTA, MTA, pemetrexed disodium) in patients with advanced
K D Miller1, J Picus, C Blanke
1Indiana University, Indianapolis, Indiana, USA.
Purpose:
To determine the safety and activity of LY231514 (ALIMTA, MTA, pemetrexed disodium, Eli Lilly and Co., Indianapolis, IN) in chemotherapy-naïve patients with advanced pancreatic cancer.
Patients And Methods:
Patients with unresectable or metastatic pancreatic cancer received LY231514 600 mg/m2 as a 10-minute infusion every three weeks.
Results:
Forty-two patients were enrolled in this phase II trial. The median age was 60.3 (range 37-77) years; 79% had metastatic disease. Neutropenia was common (40% of patients > or = grade 3) but infectious complications were rare. Significant anemia or thrombocytopenia occurred in < 20% of patients. Non-hematologic toxicities included grade 2 or 3 skin reaction which was ameliorated by dexamethasone. Elevations of bilirubin or transaminases were infrequent (< 25% of patients) and did not require dose reductions or treatment delays. Thirty-five patients received two cycles of therapy and were evaluable for response. One complete (duration 16.2 months) and one partial (duration 6.9 months) were observed resulting in an objective response rate of 5.7% for evaluable patients. In addition, 17 patients (40%) had stable disease that lasted > or = 6 months in 5 patients. The median survival was 6.5 months, with 28% of patients alive at one year.
Conclusions:
LY231514 is a well-tolerated agent with minimal objective antitumor activity in pancreatic cancer. The median and one year survival times, which may be important indicators in phase II trials of new agents, are of interest. Combination trials of LY231514 in pancreatic cancer are planned.
Insights
Pemetrexed disodium (LY231514) showed minimal antitumor activity in advanced pancreatic cancer patients. While generally well-tolerated, further combination trials are planned for this chemotherapy-naïve group.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Pancreatic cancer remains a significant challenge with limited treatment options.
- Chemotherapy-naïve patients with advanced disease require novel therapeutic strategies.
Purpose of the Study:
- To evaluate the safety and efficacy of pemetrexed disodium (LY231514) in patients with advanced pancreatic cancer who have not received prior chemotherapy.
- To establish an appropriate dose and schedule for further investigation.
Main Methods:
- A phase II clinical trial was conducted involving 42 chemotherapy-naïve patients with unresectable or metastatic pancreatic cancer.
- Patients received LY231514 at a dose of 600 mg/m2 intravenously every three weeks.
- Safety was assessed by monitoring adverse events, and efficacy was evaluated by objective response rate and disease stabilization.
Main Results:
- The most common toxicity was neutropenia (40% grade 3 or higher), but infectious complications were infrequent. Other toxicities like anemia and thrombocytopenia were less than 20%.
- Objective response rate was 5.7% (1 complete, 1 partial response) among 35 evaluable patients.
- Median survival was 6.5 months, with 28% of patients alive at one year. 40% of patients experienced stable disease for at least 6 months.
Conclusions:
- Pemetrexed disodium (LY231514) is a well-tolerated agent in this patient population.
- The drug demonstrated minimal objective antitumor activity in advanced pancreatic cancer.
- Further investigation in combination therapies is warranted and planned.
