Gastrointestinal Carcinoid TumorPhase 2NCT00602082
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
A Phase 2 study testing capecitabine, cisplatin and streptozocin in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Cambridge University Hospitals NHS Foundation Trust at 17 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- What is being tested?
- capecitabine, cisplatin and streptozocin
- How many people
- 84 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- Aug 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable, advanced, and/or metastatic disease meeting one of the following types:
- Gastroentero-neuroendocrine tumor of the foregut
- Pancreatic neuroendocrine tumor
- Neuroendocrine tumor of unknown primary
- Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (the longest diameter) ≥ 20 mm by conventional CT scanning or ≥ 10 mm by spiral CT scan or MRI
- No bronchial neuroendocrine tumors (NETs) or other NETs where the primary site is situated in organs above the diaphragm (e.g., laryngeal and pharyngeal NETs)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000/mm³
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- AST and ALT ≤ 5 times ULN
- GFR ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- No other serious or uncontrolled illness that would preclude study participation
- No medical or psychiatric condition that would influence the ability to provide consent
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior interferon therapy
- No prior systemic chemotherapy or chemotherapy administered as part of a chemo-embolization regimen, or for this condition
- No receptor-targeted radiolabeled therapy within the past 6 months
- No investigational agent within the past 4 weeks
- Prior and concurrent somatostatin analogues allowed provided symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to 6 months apart
- No palliative radiotherapy involving lesions used to measure disease
- Palliative radiotherapy to regions not involved in measurement of disease allowed
- No other concurrent chemotherapy for this condition
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Basildon University Hospital
Basildon, England, SS16 5NL
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Cookridge Hospital
Leeds, England, LS16 6QB
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Aintree University Hospital
Liverpool, England, L9 7AL
UCL Cancer Institute
London, England, NW3 2QG
St. Thomas' Hospital
London, England, SE1 7EH
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ
Christie Hospital
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
About this study
Official title: A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors
RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.
PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
Primary
- To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.
Secondary
- To determine the overall response rate, including both objective and biochemical responses, to these regimens.
- To determine the functional response to these regimens.
- To determine the toxicity of these regimens.
- To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
- To determine the progression-free and overall survival of patients receiving these regimens.
- To determine the quality of life of these patients.
- To determine molecular markers predictive of response to chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to site of origin (known vs unknown primary site), prior antitumor treatment, tumor function (functional vs nonfunctional), and study center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive streptozocin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21.
- Arm II: Patients receive cisplatin IV over 2 hours on day 1 and streptozocin and capecitabine as in arm I.
In both treatment arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the EORTC QLQC30 questionnaire and EORTC QLQ-GI.NET21 module for quality-of-life assessment at baseline, every 9 weeks during treatment, and at 12 weeks post-treatment.
Tumor tissue is obtained at baseline and assessed for Ki67 and mitotic index. Novel tissue-specific transcription factors (e.g., CDX2) are also assessed. Blood samples are collected at baseline and 9 weeks and examined by DNA, RNA, and proteomic analysis.
After completion of study therapy, patients are followed every 12 weeks.
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Being tested
- capecitabine, cisplatin, streptozocin, DNA analysis, RNA analysis
- Keywords
- pancreatic alpha cell adenoma, pancreatic alpha cell carcinoma, pancreatic beta islet cell adenoma, pancreatic beta islet cell carcinoma, pancreatic delta cell adenoma, pancreatic delta cell carcinoma, pancreatic G-cell adenoma, pancreatic G-cell carcinoma, gastrinoma, insulinoma, glucagonoma, pancreatic polypeptide tumor, somatostatinoma, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, islet cell carcinoma, recurrent islet cell carcinoma
- Medical subject headings
- Adenoma, Islet Cell, Gastrinoma, Insulinoma, Glucagonoma, Somatostatinoma, Carcinoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
cisplatinDrug
streptozocinDrug
DNA analysisGenetic
RNA analysisGenetic
protein analysisGenetic
proteomic profilingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (7)
Overall response rate
Functional response
Toxicity
Progression-free survival
Overall survival
Molecular markers predictive of response to chemotherapy
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Carcinoid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Pippa Corrie, PhD, FRCP, Cambridge University Hospitals NHS Foundation TrustTim Meyer, MD, BSc, MRCP, PhD, University College London (UCL) Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602082
- Sponsor's protocol ID
- CRCA-CCTC-NET-01
- Other IDs
- CDR0000582315, EUDRACT-2004-005202-71, EU-207102, ISRCTN35124268
- Status last verified
- Jun 2009
- First submitted
- 25 Jan 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00602082
- Acronym / sponsor ID
- CRCA-CCTC-NET-01
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Keywords
- pancreatic alpha cell adenoma, pancreatic alpha cell carcinoma, pancreatic beta islet cell adenoma, pancreatic beta islet cell carcinoma, pancreatic delta cell adenoma, pancreatic delta cell carcinoma, pancreatic G-cell adenoma, pancreatic G-cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.
PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.
Detailed description
OBJECTIVES:
Primary
- To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.
Secondary
- To determine the overall response rate, including both objective and biochemical responses, to these regimens.
- To determine the functional response to these regimens.
- To determine the toxicity of these regimens.
- To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
- To determine the progression-free and overall survival of patients receiving these regimens.
- To determine the quality of life of these patients.
- To determine molecular markers predictive of response to chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to site of origin (known vs unknown primary site), prior antitumor treatment, tumor function (functional vs nonfunctional), and study center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive streptozocin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21.
- Arm II: Patients receive cisplatin IV over 2 hours on day 1 and streptozocin and capecitabine as in arm I.
In both treatment arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the EORTC QLQC30 questionnaire and EORTC QLQ-GI.NET21 module for quality-of-life assessment at baseline, every 9 weeks during treatment, and at 12 weeks post-treatment.
Tumor tissue is obtained at baseline and assessed for Ki67 and mitotic index. Novel tissue-specific transcription factors (e.g., CDX2) are also assessed. Blood samples are collected at baseline and 9 weeks and examined by DNA, RNA, and proteomic analysis.
After completion of study therapy, patients are followed every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | – |
| cisplatin | Drug | – |
| streptozocin | Drug | – |
| DNA analysis | Genetic | – |
| RNA analysis | Genetic | – |
| protein analysis | Genetic | – |
| proteomic profiling | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Objective response rate
7 secondary outcomes
Overall response rate
Functional response
Toxicity
Progression-free survival
Overall survival
Molecular markers predictive of response to chemotherapy
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pippa Corrie, PhD, FRCP
Cambridge University Hospitals NHS Foundation Trust
Tim Meyer, MD, BSc, MRCP, PhD
University College London (UCL) Cancer Institute
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, cisplatin and streptozocin in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Cambridge University Hospitals NHS Foundation Trust at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.