Relationship Between Vitamin D Biomarkers and Survival in Blood Samples From Patients With Advanced Pancreatic Cancer

OBJECTIVES:

Primary Objective

- To measure baseline serum 25-hydroxyvitamin D (25[OH]D) levels in a cohort of patients
with advanced pancreatic cancer enrolled in the Cancer and Leukemia Group B (CALGB)
study 80303 and evaluate the association between vitamin D status and overall survival
(OS) or progression free survival (PFS).

Secondary Objective

- To evaluate the association between common germ-line single nucleotide polymorphisms
(SNPs) in the vitamin D pathway genes and 25(OH)D levels in patients with advanced
pancreatic cancer.

- To evaluate the interaction between serum 25(OH)D levels and germ-line SNPs in the
vitamin D pathway genes in predicting OS in advanced pancreatic cancer.

OUTLINE: This is a multicenter study.

Archived serum samples are analyzed for 25-hydroxyvitamin D levels by competitive
chemiluminescence immunoassay. Results are then compared with the germ-line single
nucleotide polymorphisms from the Genome-Wide Association Study (GWAS) and patients'
clinical data.

1. Eligible patients had unresectable adenocarcinoma of the pancreas

2. Received no prior therapy for metastatic disease (prior radiation and/or chemotherapy
in the adjuvant setting were allowed).

3. Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

4. Adequate renal, liver, and bone marrow function were required.

5. Patients signed informed consent for participation in the therapeutic trial and
consented to the companion study for biomarker research (CALGB-151006).