Disappointing pancreatic clinical trial results announced

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Disappointing pancreatic clinical trial results announced

On November 12, 2012, the pharmaceutical company Clovis Oncology announced the negative results of its phase II clinical trial of their experimental drug CO-101. CO-101 is a modified version of the chemotherapy drug gemcitabine.

Previous research had suggested that a protein called hENT1 was an important factor in the delivery of gemcitabine to the inside of tumor cells. The hypothesis was that patients with low hENT1 levels were likely to be resistant to gemcitabine as the drug would not be able to enter the cell where it could damage or kill it. Clovis made a modified form of gemcitabine, CO-101, designed to enter cancer cells regardless of the presence of hENT1. It was developed with the hope that it could treat patients with pancreatic cancer whose tumors have low levels of hENT1 and therefore, based on this idea, are not expected to respond to gemcitabine.

This phase II clinical trial was designed with the intent to show that CO-101 improves overall survival versus gemcitabine in patients with untreated, metastatic pancreatic adenocarcinoma whose tumors have a low level of hENT1.

Unfortunately, the data showed that there was no improvement in overall survival in patients with low hENT1 levels when treated with CO-101. Survival between the two groups was equivalent. And, the study showed that a person’s hENT1 level will not predict his/her response to treatment with gemcitabine.

We are disappointed that the results of this trial did not provide a new treatment option for pancreatic cancer patients or a method to predict whether a person’s cancer will respond to gemcitabine. However, clinical trials that do not yield positive results still have important impact. They lead researchers to change their focus and explore other ideas that may be beneficial for patients. Rigorous clinical trials are the only way that researchers can develop new treatment options for pancreatic cancer.

The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. For more information about ongoing clinical trials or any other questions about pancreatic cancer treatment or diagnosis, please contact a PanCAN Patient Services Case Manager toll-free at 877-272-6226 or complete our contact form. PanCAN Patient Services Case Managers are available M-F 7 a.m. to 5 p.m., Pacific Time.

Click here to read Clovis’ press release.