None listed
Conditions
Brief summary
177Lu-Octreotate is synthesized from [DOTA,Tyr3]Octreotate labelled with 177LuCl3 (7.8 GBq) distributed by IBD (Baarle-Nassau, the Netherlands). Each patient receives an infusion of aminoacids (Baxter Synthamin) containing 11.6g lysine and 23g arginine/L at 250 ml/hr. Thirty minutes later the radiolabelled somatostatin analogue is co-infused via a side-line over 10-20 minutes. Routine antiemetic therapy is given in the form of Tropisetron (5mg) intravenous (IV) bolus and oral Lorazepam (2mg). The chemotherapy with oral Capecitabine 1650mg/m2 will be reduced to 1500mg/m2 (in line with the American Society of Clinical Oncology (ASCO) dosage), for 14 consecutive days, and commenced on the morning of radionuclide therapy. Cycles will repeated each 8 weeks at the time of each subsequent radionuclide infusion. Temozolomide will be introduced on a dose escalation schedule, in cohorts of 3 patients, commencing at 100mg/m2 for 5 days. A standard dose escalation trial design will be followed with 3 patients completing 2 cycles at the starting dose (100mg/m2) prior to escalation to 150mg/m2 in the next 3 patient cohort. The ultimate maximum dose will not exceed the 200mg/m2 safe level established in the ASCO protocol. In the absence of toxicity all subsequent patients will be treated at this level All of the previously monitoring, including weekly blood testing and 2 monthly scanning, will remain unchanged from the original CLEMENT protocol. Assessments: Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) will be performed at baseline and then at each new treatment cycle (8 weeks). Quantitative uptake of 177Lu-octreotate in the tumours will be measured by serial whole body imaging at 4, 24, 48 hours and 5 days and graded according to a 4 point visual scale.
Interventions
This is a single arm study and all patients receive the same combination regimen as follows: Lutetium -177 octreotate radiopeptide therapy with radiosensitizing chemotherapy. Capecitabine/temozolomide
Lutetium-177 octreotate: 4 cycles at 8 week intervals
7.8 GBq per cycle intravenously on day 1
Capecitabine 1650 mg per metre squared daily for 14 days each 8 weeks for 4 cycles, oral formulation
Temozolomide 200 mg per metre squared once dai
This is a single arm study and all patients receive the same combination regimen as follows: Lutetium -177 octreotate radiopeptide therapy with radiosensitizing chemotherapy. Capecitabine/temozolomide Lutetium-177 octreotate: 4 cycles at 8 week intervals 7.8 GBq per cycle intravenously on day 1 Capecitabine 1650 mg per metre squared daily for 14 days each 8 weeks for 4 cycles, oral formulation Temozolomide 200 mg per metre squared once daily for 5 days each 8 weeks for 4 cycles, oral formulation. Every patients receives a standard amino acid solution and standard anti-nausea treatment.
Sponsors
Fremantle Hospital Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
progressive disseminated unresectable well-differentiated neuroendocrine tumours
Exclusion criteria
impaired renal function, poor performance status, poorly differentiated tumours, inadequate cardiac and hepatic function, impaired haemopoetic reserve platelets less than 100 neutrophils less than 1.5. Chemotherapy within 2 months. Residence outside Western Australia.
Outcome results
None listed