Clinical Trial: Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Study of Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
Brief Summary: The purpose of this research is to evaluate the effectiveness and safety of a combination of capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic neuroendocrine tumors.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To estimate if the combination of capecitabine and temozolomide with bevacizumab for metastatic or unresectable neuroendocrine tumors will improve response rate (RR) by 62% over historical controls (null RR of 40% to true RR 65%).
II. Assess the toxicities using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) and overall survival (OS) using Kaplan-Meier analysis.
II. To assess O6-methyl guanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) by central pathology (path) review.
III. To assess serum hormone marker levels. IV. To evaluate computed tomography (CT) Perfusion as a tool to predict early therapeutic response. (Optional) V. To bank serum for future correlative analyses.
OUTLINE:
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15, capecitabine orally (PO) twice daily (BID) on days 1-14, and temozolomide PO once daily (QD) on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up patients are followed up for 1 year.
Sponsor: Stanford University
Current Primary Outcome:
- RR % determined by RECIST v1.1 [ Time Frame: 18 months ]RR is defined as the proportion of patients with complete response + partial response (CR + PR] based on a patient's best response. The proportion of RR (CR+PR) will be estimated along with a one-sided lower 95% exact confidence bound to allow an informal assessment of the null hypothesis (RR=40%) based on binomial probabilities.
- Toxicities according to CTCAE v4.0 [ Time Frame: 18 months ]Patients will be monitored for systemic, renal, gastrointestinal, hematologic, neurological and liver toxicities. Adverse events will be tabulated by organ system and severity. Proportions will be estimated along with 95% exact confidence intervals.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- PFS (median in months) [ Time Frame: 18 months ]
- OS (median in months) [ Time Frame: 18 months ]
- MGMT by central pathology review [ Time Frame: Baseline ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: January 10, 2012
Date Started: December 2012
Date Completion: July 2019
Last Updated: September 21, 2016
Last Verified: September 2016