This trial is active, not recruiting.

Condition neuroendocrine tumors
Treatment 177lu-dotatate
Phase phase 2
Sponsor Ebrahim S. Delpassand
Collaborator Radio Isotope Therapy of America
Start date October 2010
End date August 2015
Trial size 60 participants
Trial identifier NCT01237457, 78,256


This is a phase II treatment protocol offering 177Lu-DOTATATE therapy for somatostatin receptor expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin and endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non radioiodine avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small cell lung, Carcinoid and pancreatic islet cell malignancies).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive 200mCi dose of 177Lu Dotatate

Primary Outcomes

Progression Free survival
time frame: one year after completion of last treatment cycle

Secondary Outcomes

Dose limiting toxicity
time frame: one year after completion of the fourth cycle of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids) - Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging. - Life Expectancy greater than 12 weeks. - Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min. - Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3). - Total Bilirubin ≤ 3X UNL. - Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time. - All patients must have a Karnofsky performance status of at least 60% - Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis Exclusion Criteria: - Possible surgery with curative intent. - Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy. - Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start. - Uncontrolled congestive heart failure. - Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics). - Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study - Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging. - In patients with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up. - Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. - Prior radiation therapy to more than 25% of the bone marrow. - Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment

Additional Information

Official title 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
Principal investigator Ebrahim S Delpassand, M.D
Description (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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Excel Diagnostics and Nuclear Oncology Center.