Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
NCT ID: NCT00602082
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2005-08-31
2009-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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capecitabine
cisplatin
streptozocin
DNA analysis
RNA analysis
protein analysis
proteomic profiling
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Principal Investigators
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Pippa Corrie, PhD, FRCP
Role:
Cambridge University Hospitals NHS Foundation Trust
Tim Meyer, MD, BSc, MRCP, PhD
Role:
University College London (UCL) Cancer Institute
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
UCL Cancer Institute
London, England, United Kingdom
St. Thomas' Hospital
London, 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
Royal Marsden - Surrey
Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000582315
Identifier Type: REGISTRY
Identifier Source: secondary_id
EUDRACT-2004-005202-71
Identifier Type: -
Identifier Source: secondary_id
EU-207102
Identifier Type: -
Identifier Source: secondary_id
ISRCTN35124268
Identifier Type: -
Identifier Source: secondary_id
CRCA-CCTC-NET-01
Identifier Type: -
Identifier Source: org_study_id