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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome: Objective response rate

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate
  • Functional response
  • Toxicity
  • Progression-free survival
  • Overall survival
  • Molecular markers predictive of response to chemotherapy
  • Quality of life


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 25, 2008
Date Started: August 2005
Date Completion:
Last Updated: August 6, 2013
Last Verified: June 2009