Clinical Trial: A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

Brief Summary: To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).

Detailed Summary:
Sponsor: Pamela L. Kunz

Current Primary Outcome: Response Rate (RR) for All Patients Treated With This Strategy (Simon Design) [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ]

RECIST v1.1 used


Original Primary Outcome:

  • RR for all patients treated with this strategy (Simon design)
  • PFS after erlotinib in stable patients if Simon design ends early with few progressions.


Current Secondary Outcome: Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly [ Time Frame: AEs are assessed every cycle (every 3 wks) ]

by CTCAE


Original Secondary Outcome:

  • PFS for all patients treated with this strategy
  • Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly
  • RR for patients treated with combination of pertuzumab and erlotinib


Information By: Stanford University

Dates:
Date Received: July 23, 2009
Date Started: March 2009
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017