177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms|
- Progression Free survival [ Time Frame: one year after completion of last treatment cycle ] [ Designated as safety issue: Yes ]Overall response will be determined by Progression Free Survival (PFS). PFS will be calculated as a function of time from start of therapy to time of overall disease progression. Patients will be censored at the date of last contact
- Dose limiting toxicity [ Time Frame: one year after completion of the fourth cycle of treatment ] [ Designated as safety issue: Yes ]Patients will be monitored for dose toxicity according to NCI guidelines
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Patients will receive 200mCi dose of 177Lu Dotatate
(177)Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
First Annual Report on protocol IND# 78,256 at RITA Foundation in collaboration with Excel diagnostics and Nuclear Oncology center and Baylor College of Medicine
Protocol number 78,256 calls for recruitment of sixty patients on this protocol. As of August 15th, 2011, we have enrolled 23 patients on this study ages between 27 and 83 years old with average of 61.6. Among patients there were 22 Caucasians (95.7%) and 1 African American (4.3 %). Eleven of the patients were female (48%) age between 46 and 83 years old with average of 63.9 years old. Twelve male patients (52%) were treated with ages between 27 and 86 years old with average of 59.58 years old. 15 patients (65.2%) had Gastro-entero-pancreatic neuroendocrine tumor (GEPNET), 7 had carcinoid tumors (30.4%) and 1 had bronchial carcinoid (4.3%). All patients had progressive disease with multiple distant metastases that poorly responded to prior surgery, chemotherapy, radiotherapy, chemo-embolization or cold Octreotide treatments.
Full phase I dosimetry evaluation, including dosimetric evaluation of multiple urine and blood sample collections, was performed on 6 patients and submitted to FDA. Ten patients received one therapy with an average dose of 199mCi/patient (188.52-208.15 mCi). Eight patients received two cycles of therapies with an average dose 390.29mCi/patient (363.49-413.26 mCi). Two patients received three therapies with an average dose 592.11mCi/patient (587.52-596.7mCi) and three patients have received four therapies with an average dose of 787.62mCi/patient (784.21-794.28 mCi).
Patients were evaluated for any evidence of renal, hepatic or hematologic toxicity using NCI common toxicities criteria following each cycle of therapy. No significant acute toxicity was observed immediately following treatment, and no patients required supportive treatment during therapy. Of 23 evaluable patients, 6 patients (26%) had grade 2 or 3 hematological toxicity which no supportive therapy was required. Average duration of hematological toxicities grade 2 was 8.3 weeks (range 4-16 weeks) and 4.5 weeks (range 1-8 weeks) for toxicity grade 3. Grade 2 or 3 liver toxicity was observed in 2 patients (8.6%). In addition, 2 patients (8.6%) had renal toxicity grade 2. 11 patients (47.8%) had moderate or severe nausea/vomiting after their treatment recovered between 1 to 3 days after completion of therapy. In one patient (4.3%), skin flushing, sweating and diarrhea developed after the therapy which recovered within 48 hours following the therapy.
Among 13 patients who have received 2 or more cycles of therapy, 4 (30%) had a partial response to treatment and 9 patients (70%) exhibited stable disease. No disease progression was noted.
4 patient deaths have been reported so far. None of these patients were able to complete all four cycles of the therapy. All patients died as a result of massive tumor burden. The average time interval between the death and the last treatment is 1.41 months (0.76-2.23 months).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237457
|United States, Texas|
|Excel Diagnostics and Nuclear Oncology Center|
|Houston, Texas, United States, 77042|
|Principal Investigator:||Ebrahim S Delpassand, M.D||Excel Diagnostics and Nuclear Oncology Center|