{"groups":[{"description":"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"FG000","title":"Arm I (Bortezomib+Irinotecan)"},{"description":"Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).","id":"FG001","title":"Arm II (Bortezomib)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"alternative therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"other (reasons were not specified)"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"}],"type":"ineligible/no protocol therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"41"}],"type":"Eligible"},{"achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"41"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"38"}],"type":"Eligible and Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"11 patients who progressed on bortezomib crossed over to Arm I. 10 of them were eligible","groupId":"FG001","numSubjects":"11"}],"type":"Cross Over to the Other Arm"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"}],"type":"Eligible Patients Who Cross Over"},{"achievements":[{"comment":"Treatment continued until disease progression or intolerable toxicity.","groupId":"FG000","numSubjects":"15"},{"comment":"Treatment continued until disease progression or intolerable toxicity.This number is for stage I.","groupId":"FG001","numSubjects":"32"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"E1304 was open to accrual on July 20, 2005 and was suspended on September 29, 2006. The trial was reactivated on October 18, 2006 with dose reduction for irinotecan. Arm I was closed with 27 patients after stage I. Arm B proceeded to the second stage of accrual without suspension and closed on September 24, 2008 after enrolling 44 patients."}