Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00602082|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : August 7, 2013
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 or disease||Intervention/treatment||Phase|
|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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Official Title:||A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
- Objective response rate
- Overall response rate
- Functional response
- Progression-free survival
- Overall survival
- Molecular markers predictive of response to chemotherapy
- Quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602082
|OverallOfficial:||Pippa Corrie, PhD, FRCP||Cambridge University Hospitals NHS Foundation Trust|
|OverallOfficial:||Tim Meyer, MD, BSc, MRCP, PhD||University College London (UCL) Cancer Institute|