Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
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.
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:||December 2016|
|Estimated Primary Completion Date:||December 2015 (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||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Iche Siah 415-353-7792 firstname.lastname@example.org|
|Principal Investigator: Iche Siah|
|Stanford, California, United States, 94305|
|Contact: Pamela A. Kunz 650-725-1755 email@example.com|
|Principal Investigator: Pamela Kunz|
|Sub-Investigator: George Fisher|
|Sub-Investigator: James Ford|
|Sub-Investigator: Aya Kamaya|
|United States, Florida|
|Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Helen M. Jump 813-745-4834 firstname.lastname@example.org|
|Principal Investigator: Helen M. Jump|
|Principal Investigator:||Pamela Kunz||Stanford University|