Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
- Conditions
- Gastrointestinal Carcinoid TumorIslet Cell Tumor
- Registration Number
- NCT00602082
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Overall response rate Functional response Toxicity Progression-free survival Overall survival Molecular markers predictive of response to chemotherapy Quality of life
Trial Locations
- Locations (17)
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
UCL Cancer Institute
🇬🇧London, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom