TheranosticTrials.org

Clinical Trial · NCT02358356

Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study

Overview

Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Nick Pavlakis, Associate Professor (STUDY_CHAIR)

ClinicalTrials.gov

NCT02358356

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

octreotate

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Octreotate

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
  • Life expectancy of at least 9 months;
  • Adequate renal function (measured creatinine clearance \> 50 ml/min by DTPA or 51CR-EDTA), bone marrow function (Hb \> 9 g/d/L, ANC \> 1.5 x109L, and platelets \> 100 x 10/L);
  • Progressive advanced/metastatic disease that has progressed during or after ≤ 2 prior systemic therapies;
  • ECOG performance status 0-2;
  • Ability to swallow oral medication;
  • Study treatment both planned and able to start within 28 days of randomisation; )
  • Unresectable disease, determined by an appropriately specialized surgeon or deemed not suitable for liver directed therapies where liver is the only site of disease;
  • Adequate liver function (serum total bilirubin ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases)). INR ≤ 1.5 (or on a stable dose of LMW heparin for \>2 weeks at time of enrolment .);
  • The presence of somatostatin receptor avidity suitable for PRRT demonstrated on 68Ga-octreotate PET scan;

Exclusion

  • Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception .
  • Poorly controlled concurrent medical illness. E.g. unstable diabetes (Note: optimal glycaemic control should be achieved before starting trial therapy); Symptomatic NYHA class III or IV congestive cardiac failure, myocardial infarction within 6 months of start of the study, serious uncontrolled cardiac arrhythmia, unstable angina, or any other clinically significant cardiac disease;
  • Cytotoxic chemotherapy, targeted therapy, or biotherapy within the last four weeks;
  • Primary NETs other than small bowel (midgut) or pancreatic NETs;
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of capecitabine/temozolomide (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or substantial small bowel resection);
  • Any uncontrolled known active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy;
  • Prior intrahepatic 90Y microspheres, such as SIR-Spheres in the past six months;
  • Major surgery/surgical therapy for any cause within one month;
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
  • Surgical therapy of loco-regional metastases within the last three months prior to randomisation;
  • Prior Peptide Receptor Radionuclide Therapy;
  • Uncontrolled metastatic disease to the central nervous system. To be eligible, CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time;