Condition category
Cancer
Date applied
09/12/2005
Date assigned
06/02/2006
Last edited
23/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Pippa Corrie

ORCID ID

Contact details

Oncology Centre
Box 193
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 274376
pippa.corrie@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

2004-005202-71

ClinicalTrials.gov number

NCT00602082

Protocol/serial number

N/A

Study information

Scientific title

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

South West MREC on 23/08/2005 (ref: 05/MRE06/32)

Study design

Interventional, randomised controlled trial, phase II trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Phase

Phase II

Drug names

Streptozocin, cisplatin, capecitabine

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

84; 42 in each arm

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

United Kingdom

Trial participating centre

Oncology Centre
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Box 146
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

University/education

Funder name

Addenbrookes Hospital Oncology Centre (UK) - costs of trial administration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Glasgow Pathology Department (UK) - pathological study costs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Meyer T, Qian W, Caplin ME, Armstrong G, Lao-Sirieix SH, Hardy R, Valle JW, Talbot DC, Cunningham D, Reed N, Shaw A, Navalkissoor S, Luong TV, Corrie PG, Capecitabine and streptozocin ± cisplatin in advanced gastroenteropancreatic neuroendocrine tumours., Eur. J. Cancer, 2014, 50, 5, 902-911, doi: 10.1016/j.ejca.2013.12.011.

Additional files

Editorial Notes