Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
NCT ID: NCT00514020
Last Updated: 2012-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2007-08-31
2011-02-28
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
fluorouracil
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
leucovorin calcium
through a vein over 2 hours on days 1 and 15.
oxaliplatin
500 ml D5W through a vein over 2 hours on days 1 and 15.
gene expression analysis
Blood collection
polymorphism analysis
Blood collection
protein expression analysis
Blood collection
pharmacological study
Blood collection
Interventions
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fluorouracil
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
leucovorin calcium
through a vein over 2 hours on days 1 and 15.
oxaliplatin
500 ml D5W through a vein over 2 hours on days 1 and 15.
gene expression analysis
Blood collection
polymorphism analysis
Blood collection
protein expression analysis
Blood collection
pharmacological study
Blood collection
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Laura W. Goff, MD
Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Principal Investigators
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Laura W. Goff, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VU-VICC-GI-0716
Identifier Type: -
Identifier Source: secondary_id
VICC GI 0716
Identifier Type: -
Identifier Source: org_study_id