According to the results of a Phase II clinical trial, the addition of the investigational drug EndoTAG™-1 to chemotherapy with Gemzar® (gemcitabine) may improve survival among patients with inoperable pancreatic cancer. These results were presented at the 33rd Congress of the European Society for Medical Oncology (ESMO).
Pancreatic cancer has one of the highest mortality rates of all cancers. It accounts for approximately 2% of all newly diagnosed cancers in the United States each year but 5% of all cancer deaths. Pancreatic cancer is often called a “silent killer” because its symptoms are usually not recognizable until it has advanced and spread outside the pancreas. As a result the majority of pancreatic cancers are not diagnosed until they have reached advanced stages and are considered incurable.
Chemotherapy is a common treatment for advanced pancreatic cancer. However, due to the poor long-term survival achieved with chemotherapy alone, researchers continue to evaluate novel ways to improve outcomes for these patients.
EndoTAG™-1 is an investigational drug that is intended to “starve” cancer by destroying blood vessels that supply the tumor. It binds to cells that line new blood vessels and then releases the chemotherapy drug paclitaxel.
To evaluate EndoTAG™-1 in the treatment of pancreatic cancer, researchers conducted a Phase II clinical trial among 200 patients with inoperable, locally advanced or metastatic pancreatic cancer. In addition to treatment with the chemotherapy drug Gemzar® (gemcitabine), patients were assigned to receive one of three doses of EndoTAG™-1 or a placebo.
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- 12-month survival was 17% among patients treated with Gemzar alone. Among patients treated with both Gemzar and EndoTAG™-1, survival was 22% among patients treated with the low dose of EndoTAG™-1, 36% among patients treated with the medium dose of EndoTAG™-1, and 33% among patients treated with the high dose of EndoTAG™-1.
- During the latter part of the study, patients who responded to EndoTAG™-1 had the opportunity to continue treatment with EndoTAG™-1 for a longer period of time. Among these patients 12-month survival was 25% among patients treated with the low dose of EndoTAG™-1, 52% among patients treated with medium dose of EndoTAG™-1, and 40% among patients treated with the high dose of EndoTAG™-1.
This study suggests that EndoTAG™-1 may improve survival among patients with inoperable pancreatic cancer. Dr. Mathias Löhr, the principal investigator on the study, noted that “These study data demonstrate a noticeably higher efficacy from EndoTAG™-1 treatment compared to currently available treatments for pancreatic cancer.” These results will need to be confirmed in other studies.
Patients with pancreatic cancer may wish to discuss with their physician the risks and benefits of participating in a clinical trial further evaluating this or other promising therapeutic approaches. Two sources of information about ongoing clinical trials are the National Cancer Institute (www.cancer.gov) and www.eCancerTrials.com.
Reference: MediGene press release. MediGene reports positive 12-month survival data for EndoTAG™-1from Phase II pancreatic cancer study. Available at: http://www.medigene.de/englisch/pressemitteilungen.php?ID=2599 (Accessed September 17, 2008).
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