Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors
2 other identifiers
interventional
26
1 country
4
Brief Summary
This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial therapy for an individual patient. Patients with different genetic backgrounds may respond differently to the same chemotherapy treatments. In this study the investigators will use a certain genetic difference in an important gene (thymidylate synthase or TS gene) to see whether treating patients who have a particular type of that gene will respond better to a standard chemotherapy regimen. The investigators are hoping that by treating patients according to their genes, that they may respond to treatment of their cancer better and it will help the investigators choose cancer treatments better in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2007
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
February 27, 2015
CompletedJanuary 7, 2016
December 1, 2015
4 years
August 9, 2007
February 11, 2015
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
* ORR = complete response + partial response * Complete response - disappearance of all target and non-target lesions * Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
2 years
Secondary Outcomes (18)
Overall Survival
4 years
Progression-free Survival (PFS)
4 years
Disease Control Rate (DCR)
2 years
Tumor Specific Changes That May Alter Treatment Outcomes
4 years
Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)
4 years
- +13 more secondary outcomes
Study Arms (1)
Oxaliplatin/Leucovorin/5-FU
EXPERIMENTAL"Good risk" patients with the TSER\*2/\*2 or \*2/\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- Patients must have measurable disease.
- No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is permitted if the disease free interval has been longer than 6 months.
- Age ≥18 years.
- Life expectancy of greater than 3 months.
- ECOG (Eastern Cooperative Oncology Group) performance status greater than 2 (Karnofsky greater than 60%).
- Patients must have normal organ and marrow function.
- Not pregnant. Not breast feeding.
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- Patients may not be receiving any other chemotherapy agents.
- Patients with known active brain metastases. Patients with treated brain metastases are permitted if stable off steroids for at least 30 days.
- History of allergic reactions to 5-FU or oxaliplatin.
- Uncontrolled intercurrent illness.
- Patients with immune deficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- University of Alabama at Birminghamcollaborator
- University of North Carolinacollaborator
- Washington University School of Medicinecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (4)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Goff LW, Thakkar N, Du L, Chan E, Tan BR, Cardin DB, McLeod HL, Berlin JD, Zehnbauer B, Fournier C, Picus J, Wang-Gillam A, Lee W, Lockhart AC. Thymidylate synthase genotype-directed chemotherapy for patients with gastric and gastroesophageal junction cancers. PLoS One. 2014 Sep 18;9(9):e107424. doi: 10.1371/journal.pone.0107424. eCollection 2014.
PMID: 25232828DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- A. Craig Lockhart, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Albert C. Lockhart, M.D.
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Laura Goff, M.D.
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Richard Goldberg, M.D.
University of North Carolina
- PRINCIPAL INVESTIGATOR
James Posey, M.D.
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 13, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2011
Study Completion
November 1, 2013
Last Updated
January 7, 2016
Results First Posted
February 27, 2015
Record last verified: 2015-12