Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With 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.
|Gastrointestinal Carcinoid Tumor Islet Cell Tumor||Drug: capecitabine Drug: cisplatin Drug: streptozocin Genetic: DNA analysis Genetic: RNA analysis Genetic: protein analysis Genetic: proteomic profiling Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors|
- Objective response rate
- Overall response rate
- Functional response
- Progression-free survival
- Overall survival
- Molecular markers predictive of response to chemotherapy
- Quality of life
|Study Start Date:||August 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602082
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds, England, United Kingdom, LS16 6QB|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|UCL Cancer Institute|
|London, England, United Kingdom, NW3 2QG|
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 7EH|
|Mid Kent Oncology Centre at Maidstone Hospital|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|OverallOfficial:||Pippa Corrie, PhD, FRCP||Cambridge University Hospitals NHS Foundation Trust|
|OverallOfficial:||Tim Meyer, MD, BSc, MRCP, PhD||University College London (UCL) Cancer Institute|