UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol No.CTSU-E2211Principal InvestigatorBergsland, Emily
PhaseII (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.E2211
TitleA Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors
ObjectivePrimary Endpoints To evaluate PFS associated with temozolomide alone or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors. Secondary Endpoints To evaluate: -the response rates (RR), overall survival (OS), and toxicity associated with temozolomide alone or temozolomide and capecitabine treatment -the usefulness of MGMT status (by IHC and promoter methylation) for predicting responses To bank radiology images for evaluation of quality, reproducibility, and compliance with CT methodology.
Key EligibilityAge: 18+ * Histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor, excluding small cell carcinoma * Must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy
Applicable Disease SitesPancreas
Participating InstitutionsMt. Zion
Eligibility DocumentCTSU-E2211_CTGovEligibility_NCT01824875.doc