177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
(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).
Toxicity
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.
Response
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).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free survival
Overall response will be determinine 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 sensored at the date of last contact
one year after completion of last treatment cycle
Yes
Ebrahim S Delpassand, M.D
Principal Investigator
Excel Diagnostics and Nuclear Oncology Center
United States: Food and Drug Administration
78,256
NCT01237457
October 2010
October 2013
Name | Location |
---|---|
Excel Diagnostics and Nuclear Oncology Center | Houston, Texas 77042 |