Back to resultsCapecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
Primary Purpose
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
capecitabine
cisplatin
streptozocin
DNA analysis
RNA analysis
protein analysis
proteomic profiling
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring 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, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, islet cell carcinoma, recurrent islet cell carcinoma
Eligibility 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
Sites / Locations
- Basildon University Hospital
- Addenbrooke's Hospital
- Cookridge Hospital
- Leicester Royal Infirmary
- Aintree University Hospital
- UCL Cancer Institute
- St. Thomas' Hospital
- Mid Kent Oncology Centre at Maidstone Hospital
- Christie Hospital
- Clatterbridge Centre for Oncology
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Oxford Radcliffe Hospital
- Royal Marsden - Surrey
- Southend University Hospital NHS Foundation Trust
- Edinburgh Cancer Centre at Western General Hospital
- Beatson West of Scotland Cancer Centre
- Velindre Cancer Center at Velindre Hospital
Outcomes
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
Full Information
NCT ID
NCT00602082
First Posted
January 25, 2008
Last Updated
August 6, 2013
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00602082
Brief Title
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
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 Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
Keywords
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, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, islet cell carcinoma, recurrent islet cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
streptozocin
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Genetic
Intervention Name(s)
proteomic profiling
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Objective response rate
Secondary Outcome Measure Information:
Title
Overall response rate
Title
Functional response
Title
Toxicity
Title
Progression-free survival
Title
Overall survival
Title
Molecular markers predictive of response to chemotherapy
Title
Quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pippa Corrie, PhD, FRCP
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
First Name & Middle Initial & Last Name & Degree
Tim Meyer, MD, BSc, MRCP, PhD
Organizational Affiliation
University College London (UCL) Cancer Institute
Facility Information:
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Mid Kent Oncology Centre at Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
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