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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE January 28, 2008
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Objective response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Overall response rate
  • Functional response
  • Toxicity
  • Progression-free survival
  • Overall survival
  • Molecular markers predictive of response to chemotherapy
  • Quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
Official Title  ICMJE A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: cisplatin
  • Drug: streptozocin
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: protein analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
84
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00602082
Other Study ID Numbers  ICMJE CRCA-CCTC-NET-01
CDR0000582315 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT-2004-005202-71
EU-207102
ISRCTN35124268
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
Investigator: Tim Meyer, MD, BSc, MRCP, PhD University College London (UCL) Cancer Institute
PRS Account National Cancer Institute (NCI)
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP