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| Sponsored by: |
Cambridge University Hospitals NHS Foundation Trust |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00602082 |
Purpose
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.
| Condition | Intervention | Phase |
|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor |
Drug: capecitabine Drug: cisplatin Drug: streptozocin Procedure: DNA analysis Procedure: RNA analysis Procedure: laboratory biomarker analysis Procedure: protein analysis Procedure: proteomic profiling |
Phase II |
| MedlinePlus related topics: | Cancer Carcinoid Tumors |
| ChemIDplus related topics: | Cisplatin Capecitabine Streptozocin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors |
| Estimated Enrollment: | 84 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable, advanced, and/or metastatic disease meeting one of the following types:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No palliative radiotherapy involving lesions used to measure disease
Contacts and Locations| United Kingdom, England | |||||
| Addenbrooke's Hospital | Recruiting | ||||
| Cambridge, England, United Kingdom, CB2 2QQ | |||||
| Contact: Contact Person 44-1223-245-151 | |||||
| Christie Hospital | Recruiting | ||||
| Manchester, England, United Kingdom, M20 4BX | |||||
| Contact: Contact Person 44-161-4468-8102 | |||||
| Cookridge Hospital | Recruiting | ||||
| Leeds, England, United Kingdom, LS16 6QB | |||||
| Contact: Contact Person 44-113-267-3411 | |||||
| Leicester Royal Infirmary | Recruiting | ||||
| Leicester, England, United Kingdom, LE1 5WW | |||||
| Contact: Contact Person 44-116-254-1414 | |||||
| Mid Kent Oncology Centre at Maidstone Hospital | Recruiting | ||||
| Maidstone, England, United Kingdom, ME16 9QQ | |||||
| Contact: Contact Person 44-1622-729-000 | |||||
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting | ||||
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |||||
| Contact: Contact Person 44-191-233-6161 | |||||
| Royal Marsden - Surrey | Recruiting | ||||
| Sutton, England, United Kingdom, SM2 5PT | |||||
| Contact: Contact Person 44-208-642-6044 | |||||
| St. Thomas' Hospital | Recruiting | ||||
| London, England, United Kingdom, SE1 7EH | |||||
| Contact: Contact Person 44-207-188-7188 | |||||
| UCL Cancer Institute | Recruiting | ||||
| London, England, United Kingdom, NW3 2QG | |||||
| Contact: Contact Person 44-207-794-2500 | |||||
| United Kingdom, Scotland | |||||
| Beatson West of Scotland Cancer Centre | Recruiting | ||||
| Glasgow, Scotland, United Kingdom, G12 0YN | |||||
| Contact: Contact Person 44-141-301-7057 | |||||
| Edinburgh Cancer Centre at Western General Hospital | Recruiting | ||||
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |||||
| Contact: Contact Person 44-131-537-1000 | |||||
| Cambridge University Hospitals NHS Foundation Trust |
| Investigator: | Pippa Corrie, PhD, FRCP | Cambridge University Hospitals NHS Foundation Trust |
| Investigator: | Tim Meyer, MD, BSc, MRCP, PhD | UCL Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000582315, CRCA-CCTC-NET-01, EUDRACT-2004-005202-71, EU-207102, ISRCTN35124268 |
| First Received: | January 25, 2008 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00602082 |
| Health Authority: | Unspecified |
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