Study design and statistical plan
toxicity, toxicities, tumor, pain
DISEASE, DISEASE PROGRESSION, TUMOR, METASTASIS
Patients had physical exam, assessment of toxicity and performance status, as well as tumor assessment by PET-CT imaging, at the beginning of study, after 4 weeks, 8 weeks, and then every 8 weeks thereafter. Efficacy was evaluated by SUVmax of a metastatic lesion by 18 F-FDG PET-CT imaging, a surrogate marker of tumor response. An objective response was recorded if the tumor demonstrated a decrease in FDG uptake (SUVmax) from baseline by 50% or greater in at least one of the metastatic sites as measured by PET-CT imaging. Stable disease was defined as SUVmax maintained at or decreased by < 50% from the baseline level. RECIST 1.1 was used to evaluate objective responses [Patients with objective response to therapy or disease stabilization by PET-CT SUVmax were allowed to continue treatment on study after the initial 4-week assessment. Treatment and study participation was discontinued if the patient developed pain that required narcotics, disease progression as noted by increasing SUVmax or presence of new metastasis, grade 3 or 4 toxicities that do not resolve within 4 weeks of holding therapy, did not tolerate dose reduction to 5 mg every other day, became pregnant or failed to use adequate birth control or if the treating physician decided to change therapy in the best interest of the patient. Patients were also followed for overall survival.A Simon two-stage phase II design [