A randomised phase II study comparing capecitabine plus streptozocin with or without cisplatin in the treatment of unresectable or metastatic gastroentero-neuroendocrine tumours of the foregut, pancreatic neuroendocrine tumours and neuroendocrine tumours of unknown primary site

Phase 2

Completed

• Conditions: euroendocrine tumour; Cancer; Neuroendocrine tumour

• Registration Number: ISRCTN35124268
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24445147

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-06
• Study Completion: 2009-05-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Patients with histological confirmation of resectable, advanced and/or metastatic:
1.1. Gastroentero-neuroendocrine tumour of the foregut
1.2. Pancreatic neuroendocrine tumour
1.3. Neuroendocrine tumour of unknown primary source
2. Measureable disease, defined by the presence of at least one lesion which can be accurately measured in at least one dimension with longest diameter more than 20 mm using conventional Computed Tomography (CT) scanning, or more than 10 mm with spiral CT or Magnetic Resonance Imaging (MRI)
3. No prior or concomitant chemotherapy or immunotherapy administered for this condition
4. Life expectancy more than 12 weeks
5. Performance status zero, one or two (Eastern Cooperative Oncology Group [ECOG] performance scale)
6. Aged over 18 years

Exclusion Criteria

1. Bronchial NETs
2. No previous systemic chemotherapy or chemotherapy administered as part of a chemo-embolisation regimen is allowed. Prior interferon is allowed. In this case, the time interval between the last dose of interferon and the date of commencing chemotherapy within this trial should be at least three weeks
3. Any previous investigational agent within the last four weeks. Patients may have previously received somatostatin analogues. Patients on somatostatin analogues are eligible to enter the study if their symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to six months apart, as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. At the time of trial entry, it is acceptable for the patient to continue their somatostatin analogue therapy or to stop it, depending on individual circumstances
4. Palliative radiotherapy involving any of the lesion(s) being used to measure disease. Palliative radiotherapy to regions not involved in measurement of disease is permitted.
5. Any other serious or uncontrolled illness, which in the opinion of the investigator, makes it undesirable for the patient to enter the trial
6. Any medical or psychiatric condition which would influence the ability to provide informed consent
7. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate.

Secondary Outcome Measures

Name	Time	Method
1. Overall response rate, to include both objective and biochemical responses<br>2. Functional response<br>3. Toxicity of both combination regimens<br>4. To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial<br>5. Progression-free survival<br>6. Overall survival<br>7. Quality of life<br>8. Molecular markers predictive of response to chemotherapy