Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
Pancreatic Polypeptide Tumor
Recurrent Islet Cell Carcinoma
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors|
- RR % determined by RECIST v1.1 [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
- PFS (median in months) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- OS (median in months) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- MGMT by central pathology review [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: monoclonal antibody therapy, chemotherapy
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, capecitabine PO BID on days 1-14, and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: temozolomide
Other Names:Biological: bevacizumab
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525082
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Stanford, California, United States, 94305|
|United States, Florida|
|Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Pamela Kunz||Stanford University|