SHIVA trial studying response to molecular targeting strategy for drug therapy


At the upcoming meeting of the European Cancer Congress (ECC2013), starting on Friday, September 27 in Amsterdam, The Netherlands, Dr. Christophe Le Tourneau, Head of the Phase I Program at the Institut Curie, Paris, France, will give attendees an initial report on progress of the so-called SHIVA trial.

Why is this important?

The SHIVA trial is a randomized, Phase II study, designed to enroll about 1,000 patients (at selected French comprehensive cancer centers) who have recurrent or metastatic solid tumors that are unresponsive to standard treatment for their disease. It is projected that, of those roughly 1,000 patients, about 200 will actually be randomized to either conventional therapy (i.e., the type of therapy that the patients would have got if they were not participating in this trial) or to a form of therapy selected on the basis of the molecular profile of the tumor they are dealing with. It is the first large, randomized, clinical trial of this type, and it will presumably include at least some patients with prostate cancer because abiraterone acetate is one of the study drugs.

According to information available on the Science Codex web site, some 320 patients  have been enrolled in this phase II trial to date (at seven French comprehensive cancer centers), and 60 of those patients (about 19 percent) have been randomized to one or other arm of the study.

Dr. Le Tourneau is quoted as follows:

Although 40 percent of the 320 patients have a tumor for which targeted drugs are available, some are still on the chemotherapy that was started at the time of the biopsy and therefore we will have to randomize them later. Because we are looking for an effect in different kinds of tumors, we have ruled out the inclusion of any particular type of tumor if this brings the number of randomized patients with this type to over 20 percent of the total. We have also allowed the inclusion of patients with rare tumors.

The data to be presented in Amsterdam are preliminary results from the “feasibility” phase of the study. Once the first 100 patients were enrolled, the research team was able to determine whether biopsies could be conducted regularly to obtain cancer tissue from a site of metastasis. This was important because the molecular profile metastatic cancer is not always the same as the molecular profile of tissue from of the primary tumor (if such tissue is even available). They were also able to assess things like the quality of available tumor samples, the proportion of the patients among whom the necessary analyses could be undertaken, the proportion among whom a molecular abnormality could be identified (and for which a targeted therapy exists), and the timeframe needed to establish the tumor profile.

The long-term goal of the SHIVA trial is to be able to tell whether the selection of drugs that target tumors that have specific molecular profiles can improve long-term outcomes for patients.

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