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Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602082
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
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
Study Start Date : August 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Overall response rate
  2. Functional response
  3. Toxicity
  4. Progression-free survival
  5. Overall survival
  6. Molecular markers predictive of response to chemotherapy
  7. Quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00602082

Show Show 17 study locations
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
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OverallOfficial: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
OverallOfficial: Tim Meyer, MD, BSc, MRCP, PhD University College London (UCL) Cancer Institute
Layout table for additonal information Identifier: NCT00602082    
Other Study ID Numbers: CRCA-CCTC-NET-01
CDR0000582315 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
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
pancreatic polypeptide tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
islet cell carcinoma
recurrent islet cell carcinoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic