Clinical Trial: TEMCAP in Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 2 Study of Temozolomide Plus Capecitabine in Patients With Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors

Brief Summary: GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors. Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination with cisplatin, has been the mainstay of the treatment for patients with grade 3 neuroendocrine tumors. However, a recent large retrospective analysis has suggested this regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the investigators designed a clinical trial testing temozolomide-capecitabine combination, which has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.

Detailed Summary:
Sponsor: Asan Medical Center

Current Primary Outcome: Response rate [ Time Frame: 2 years ]

Proportion of patients with complete or partial response graded by Response Evaluation Criteria in Solid Tumors version 1.1


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival [ Time Frame: 2 years ]
    Time between the start of study treatment and disease progression
  • Overall survival [ Time Frame: 2 years ]
    Time between the start of study treatment and survival
  • Toxicity (Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03) [ Time Frame: 2 years ]
    Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: March 9, 2017
Date Started: May 2017
Date Completion: October 2020
Last Updated: March 13, 2017
Last Verified: March 2017