NCT00514020

Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Detailed description

OBJECTIVES: Primary * 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 selected patients. 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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
DRUG	leucovorin calcium	through a vein over 2 hours on days 1 and 15.
DRUG	oxaliplatin	500 ml D5W through a vein over 2 hours on days 1 and 15.
GENETIC	gene expression analysis	Blood collection
GENETIC	polymorphism analysis	Blood collection
GENETIC	protein expression analysis	Blood collection
OTHER	pharmacological study	Blood collection

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2007-08-09
• Last updated: 2012-11-01
• Results posted: 2012-10-18

Locations

5 sites across 1 country: United States