Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
- Compare the response rate in patients with "good risk" genotype (TSER*2/*2 or TSER*2/*3
genotype [low TS expression]) to historical control response rates in non-genotype
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses
repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein
levels. The results are correlated with germline and tumor TSER genotypes as well as
response to the study treatment regimen. Polymorphisms in other genes associated with
treatment outcome or toxicity are also assessed.
After completion of study treatment, patients are followed periodically for 4 years.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.
every 8 weeks to progression
Laura W. Goff, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0716
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|