Back to resultsFluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
leucovorin calcium
oxaliplatin
gene expression analysis
polymorphism analysis
protein expression analysis
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring adenocarcinoma of the stomach, stage IV gastric cancer, recurrent gastric cancer
Eligibility Criteria
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
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
Sites / Locations
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Vanderbilt-Ingram Cancer Center - Cool Springs
- Vanderbilt-Ingram Cancer Center at Franklin
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00514020
First Posted
August 8, 2007
Last Updated
October 30, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00514020
Brief Title
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Official Title
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
adenocarcinoma of the stomach, stage IV gastric cancer, recurrent gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Description
through a vein over 2 hours on days 1 and 15.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
500 ml D5W through a vein over 2 hours on days 1 and 15.
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Description
Blood collection
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Description
Blood collection
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Description
Blood collection
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Description
Blood collection
Primary Outcome Measure Information:
Title
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])
Description
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.
Time Frame
every 8 weeks to progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura W. Goff, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
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Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
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