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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514020
Recruitment Status : Completed
First Posted : August 9, 2007
Results First Posted : October 18, 2012
Last Update Posted : November 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Genetic: gene expression analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: pharmacological study Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
Study Start Date : August 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Treatment 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

Primary Outcome Measures :
  1. 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]) [ Time Frame: every 8 weeks to progression ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

    • Metastatic disease
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
  • No known active brain metastases

    • Patients with treated brain metastases are eligible if stable off steroids for at least 30 days


  • ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)
  • Creatinine clearance ≤ 1.5 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 21 days after completion of study treatment
  • No history of allergic reactions to fluorouracil or oxaliplatin
  • No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements


  • No prior therapy for metastatic disease

    • Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months
  • No other concurrent chemotherapy
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent routine prophylaxis with filgrastim (G-CSF)
  • No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514020

United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States, 63110
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Laura W. Goff, MD Vanderbilt-Ingram Cancer Center

Additional Information:
Responsible Party: Laura W. Goff, MD, Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00514020     History of Changes
Other Study ID Numbers: VICC GI 0716
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2007    Key Record Dates
Results First Posted: October 18, 2012
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center:
adenocarcinoma of the stomach
stage IV gastric cancer
recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents