Trial record 16 of 40 for:
Open Studies | "Carcinoid Tumor"
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00602082
First received: January 25, 2008
Last updated: July 15, 2009
Last verified: June 2009
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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 Genetic: DNA analysis Genetic: RNA analysis Genetic: protein analysis Genetic: proteomic profiling Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response rate
Secondary Outcome Measures:
- Overall response rate
- Functional response
- Toxicity
- Progression-free survival
- Overall survival
- Molecular markers predictive of response to chemotherapy
- Quality of life
| Estimated Enrollment: | 84 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602082
Locations
| United Kingdom | |
| Basildon University Hospital | Recruiting |
| Basildon, England, United Kingdom, SS16 5NL | |
| Contact: Contact Person 44-1702-435-555 | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Contact Person 44-1223-245-151 | |
| 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 | |
| Aintree University Hospital | Recruiting |
| Liverpool, England, United Kingdom, L9 7AL | |
| Contact: Research Nurse 44-151-529-5873 | |
| 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 | |
| Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Contact: Contact Person 44-1622-729-000 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Contact Person 44-161-4468-8102 | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Contact Person 44-151-334-1155 | |
| 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 | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Contact: Research Nurse 44-186-522-6173 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Contact Person 44-208-642-6044 | |
| Southend University Hospital NHS Foundation Trust | Recruiting |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Contact: Contact Person 44-1702-435-555 | |
| Edinburgh Cancer Centre at Western General Hospital | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Contact: Contact Person 44-131-537-1000 | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Contact: Contact Person 44-141-301-7057 | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Contact: Contact Person 44-29-2061-5888 | |
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
| Investigator: | Pippa Corrie, PhD, FRCP | Cambridge University Hospitals NHS Foundation Trust |
| Investigator: | Tim Meyer, MD, BSc, MRCP, PhD | University College London (UCL) Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00602082 History of Changes |
| Other Study ID Numbers: | CDR0000582315, CRCA-CCTC-NET-01, EUDRACT-2004-005202-71, EU-207102, ISRCTN35124268 |
| Study First Received: | January 25, 2008 |
| Last Updated: | July 15, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor pancreatic alpha cell adenoma pancreatic alpha cell carcinoma pancreatic beta islet cell adenoma pancreatic beta islet cell carcinoma pancreatic delta cell adenoma pancreatic delta cell carcinoma |
pancreatic G-cell adenoma pancreatic G-cell carcinoma gastrinoma insulinoma glucagonoma pancreatic polypeptide tumor somatostatinoma islet cell carcinoma recurrent islet cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoid Tumor Malignant Carcinoid Syndrome Neuroendocrine Tumors Gastrointestinal Neoplasms Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Adenoma Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Capecitabine Cisplatin Streptozocin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013