A multicentre study comparing treatment of patients with neuroendocrine gastro-entero-pancreatic tumours with 177Lu-octreotate versus combined 177Lu-octreotate and capecitabine treatment

Not Applicable

Completed

• Conditions: euroendocrine gastro-entero-pancreatic tumours; Cancer; Neuroendocrine tumours

• Registration Number: ISRCTN30356763
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-07
• Study Completion: 2010-03-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Presence of histology proven Gastro-Entero-Pancreatic (GEP) tumour(s), including bronchial carcinoids
2. Presence of somatostatin-receptors on the known tumour lesions demonstrated by OctreoScan® within six months of the first dose of radio-labelled octreotate/octreotide. The uptake on the OctreoScan® should be at least as high as normal liver uptake on planar imaging
3. Life expectancy greater than 12 weeks
4. Serum creatinine less than than 150 µmol/litre or 1.7 mg/dL, and a measured creatinine clearance (or measured Glomerular Filtration Rate [GFR] using plasma clearance methods, not gamma-camera based) of greater than or equal to 50 mL/min
5. Haemoglobin (Hgb) concentration greater than or equal to 5.5 mmol/L (greater than or equal to 8.9 g/dL); White Blood Cells (WBC) greater than or equal to 2 x 10^9/L (2000/mm^3); platelets greater than or equal to 100 x 10^9/L (100 x 10^3/mm^3)
6. Total bilirubin less than 3 x Upper Limit of Normal (ULN)
7. Serum albumin less than 30 g/L, or serum albumin greater than or equal to 30 g/L but normal prothrombin time
8. Karnofsky Performance Status greater than or equal to 60
9. Presence of at least one measurable site of disease
10. Patient’s written voluntary informed consent to participate in the study, obtained prior to enrolment into the study. The informed consent must be maintained in the investigator's study files

Exclusion Criteria

1. Possible surgery with curative intent
2. Surgery, radiotherapy, chemotherapy, or other investigational therapy within three months of the start of therapy
3. Patients with known brain metastases unless these metastases have been treated and stabilised for at least six months prior to study start. Patients with a history of brain metastases must have a head Computed Tomography (CT) with contrast to document stable disease prior to study start
4. Uncontrolled congestive heart failure
5. Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics)
6. Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least three months prior to the first cycle in this study and the disease status during these three months has been documented by South West Oncology Group (SWOG) criteria as described in this study
7. 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 receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least six weeks before the administration of the radio-labelled 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
8. In patients with unusual haematological parameters, including an increased Mean red Cell Volume (MCV) (greater than 105 fL), and especially in those who had previous chemotherapy, the advice of a haematologist should be sought, for adequate further work-up
9. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
10. Pregnancy
11. Prior radiation therapy to more than 25% of the bone marrow

Study & Design

• Study Type: Interventional
• Study Design: Not specified