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
| ISRCTN | ISRCTN35124268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35124268 |
| EudraCT/CTIS number | 2004-005202-71 |
| ClinicalTrials.gov number | NCT00602082 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/12/2005
- Registration date
- 06/02/2006
- Last edited
- 19/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Pippa Corrie
Scientific
Scientific
Oncology Centre
Box 193
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 274376 |
|---|---|
| pippa.corrie@addenbrookes.nhs.uk |
Study information
| Study design | Interventional, randomised controlled trial, phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | NET 01 |
| Study hypothesis | What are the objective response rates of two chemotherapy regimens being tested in patients with unresectable or metastatic NeuroEndocrine Tumours (NET) originating from the stomach, duodenum, pancreas or from an unknown primary site? |
| Ethics approval(s) | South West MREC on 23/08/2005 (ref: 05/MRE06/32) |
| Condition | Neuroendocrine tumour |
| Intervention | Patients will be randomised to one of two groups: 1. Streptozocin (Zanosar) injection on the first day of every three week cycle 2. Streptozocin (Zanosar) and cisplatin injections on the first day of each three week cycle Each patient will have up to six cycles of chemotherapy treatment over 18 weeks. One treatment cycle will last three weeks (21 days). Both groups will also be taking capecitabine (Xeloda) tablets continuously, twice a day, for 18 weeks. Patients will be asked to fill in a quality of life questionnaire before they start treatment, every nine weeks during the treatment and 12 weeks after the last treatment. Patients will also have CT and MRI scans every three cycles (nine weeks) while they are having the treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Streptozocin, cisplatin, capecitabine |
| Primary outcome measure | Objective response rate. |
| Secondary outcome measures | 1. Overall response rate, to include both objective and biochemical responses 2. Functional response 3. Toxicity of both combination regimens 4. To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial 5. Progression-free survival 6. Overall survival 7. Quality of life 8. Molecular markers predictive of response to chemotherapy |
| Overall study start date | 01/06/2005 |
| Overall study end date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84; 42 in each arm |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2005 |
| Recruitment end date | 31/05/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrookes Hospital
Box 146
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/04v54gj93 |
|---|
Funders
Funder type
University/education
Addenbrookes Hospital Oncology Centre (UK) - costs of trial administration
No information available
University of Glasgow Pathology Department (UK) - pathological study costs
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/03/2014 | Yes | No |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
