Conditions: Gastric Cancer
Keywords: adenocarcinoma of the stomach stage IV gastric cancer recurrent gastric cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None

Interventions: intervention 1: fluorouracil intervention 2: leucovorin calcium intervention 3: oxaliplatin intervention 4: gene expression analysis intervention 5: polymorphism analysis intervention 6: protein expression analysis intervention 7: pharmacological study
Intervention descriptions: intervention 1: Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15. intervention 2: through a vein over 2 hours on days 1 and 15. intervention 3: 500 ml D5W through a vein over 2 hours on days 1 and 15. intervention 4: Blood collection intervention 5: Blood collection intervention 6: Blood collection intervention 7: Blood collection

Protocol document: