Phase II trials for mesothelioma enroll a larger number of participants than Phase I trials (usually 100 or less), and are designed to evaluate the effectiveness of the drug, while also taking into consideration its continued safety. Phase II trials often focus on cancers for which no effective treatment currently exists.
In most Phase II trials, all participants receive the same dosage of the investigational drug. The drug is then assessed for its effectiveness and additional information regarding its safety is noted. Even when a drug appears to be beneficial, it most often requires further testing before being more widely used. Also, because it has not been tested against a current standard of therapy, its value remains unclear, and longer trials are necessary to determine long-term benefits. Phase III trials are better suited for this purpose.
Some Phase II trials use different groups of participants to compare different schedules of administering the same drug. In these types of trials, participants are randomly assigned to either an investigational group, which receives the new treatment, or a control group, which receives the standard treatment. Neither participants nor their doctor can choose into which group an individual will be placed. When the trial closes, the most promising regimen will be chosen for a Phase III trial.
In general, mesothelioma patients who take part in Phase II trials have shown little or no response to the current standard of treatment (Alimta/cisplatin). In order to be eligible for Phase II trials, participants are required to have adequate organ function, have at least a 3 month life expectancy and a limited number of prior treatments. Eligibility requirements may vary from one drug trial to another, however, and it is always best to check with a medical professional to determine which trial may be the most appropriate.