For more information on this trial see ClinicalTrials.gov
This trial is now open at Stanford University for more information contact: Vilay Khandelwal, 650-724-9057,
This trial is now open at Cedars Sinai in Los Angeles - The Principal Investigator is Edward M. Wolin, MD. Interested patients can call the Clinical Trial Recruitment Navigator at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute at (310) 423-2133 or
A multicenter, stratified, open, randomized,comparator-controlled, parallel-group phase III study. In this study, treatment with 177Lu-DOTA0-Tyr3-Octreotate plus best supportive care (30 mg Octreotide LAR) will be compared to treatment with high dose (60 mg) Octreotide LAR in patients with inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours; these patients should be progressive under Octreotide LAR. In case patients in either arm experience clinical symptoms (i.e. diarrhea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections are allowed.
Objective tumor response in both arms will be assessed every 12 weeks from the first treatment date according to RECIST Criteria. The baseline CT scan/MRI must not be older than 4 weeks before the projected randomization date.
Patients will be evaluated for safety and tolerability in accordance with the Visit Schedules for the 177Lu-DOTA0-Tyr3-Octreotate arm and the Octreotide LAR arm as indicated in Table 1 and Table 2, respectively.
Estimated Enrollment: 200 Study Start Date: April 2012
Estimated Study Completion Date: December 2017 Estimated Primary
Completion Date:December 2014 (Final data collection date for primary outcome measure)