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| Sponsors and Collaborators: |
Vanderbilt University Washington University School of Medicine University of Alabama at Birmingham University of North Carolina |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00515216 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms Esophageal Neoplasms |
Drug: Chemotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal (GEJ) Tumors: A Phase II Study |
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment: Experimental
"Good risk" patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype
|
Drug: Chemotherapy
5-FU, leucovorin and oxaliplatin (FOLFOX)
|
Gastric and gastroesophageal junction (GEJ) cancers are a leading cause of cancer mortality. Despite the development of newer chemotherapies, the response rates and median survival in patients with these tumors has remained essentially stagnant. Defining host and molecular/biologic tumor characteristics to customize treatment may lead to improved survival outcomes. Retrospective studies have identified genetic markers that predict treatment outcome. However, there have been no prospective studies in gastric and GEJ cancer evaluating the clinical utility of these genetic factors. We hypothesize that genomically based treatment will improve the expected response rate in patients with gastric and GEJ cancers. We propose a prospective, multi-institutional Phase II clinical trial testing a germline polymorphism in the thymidylate synthase (TS) gene, the number of tandem repeats in the TS enhancer region (TSER) as a treatment selection marker. The polymorphic variant conferring three tandem repeats (TSER*3) has been associated with 5-FU resistance due to high tumor TS expression in comparison to the TSER*2 variant (two tandem repeats). The TSER*3 polymorphism is common (allelic frequency of 0.5-0.8). In the proposed study, we will prospectively genotype patients with gastric and GEJ cancers. Patients who are expected to be 5-FU sensitive (carrying a TSER*2 allele) will receive a 5-FU containing regimen (5-FU, leucovorin, oxaliplatin). Patients who are expected to be 5-FU resistant (homozygous for TSER*3) will not be included in the study. In completing this study, we will determine whether treatment selection based on germline TSER polymorphism status improves the response rate in patients with metastatic gastric and GEJ tumors. Additional correlative studies are proposed to identify confounding factors that may alter the expected outcomes of this treatment approach.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Albert C. Lockhart, MD | (615) 936-1796 | craig.lockhart@vanderbilt.edu |
| Contact: Karen E. Liebler, RN | (615) 936-5747 | karen.liebler@vanderbilt.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: James Posey, MD 205-934-0916 james.posey@ccc.uab.edu | |
| Principal Investigator: James Posey, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Ben Tan, MD 314-362-9115 btan@im.wustl.edu | |
| Principal Investigator: Ben Tan, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Bert O'Neil, MD 919-843-7180 bert_oneil@med.unc.edu | |
| Principal Investigator: Bert O'Neil, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Albert C. Lockhart, MD 615-936-1796 craig.lockhart@vanderbilt.edu | |
| Contact: Karen E. Liebler, RN (615) 936-5747 karen.liebler@vanderbilt.edu | |
| Principal Investigator: Albert C. Lockhart, MD | |
| Principal Investigator: | Albert C. Lockhart, MD | Vanderbilt University |
| Principal Investigator: | Benjamin Tan, MD | Washington University School of Medicine |
| Principal Investigator: | Bert O'Neil, MD | University of North Carolina |
| Principal Investigator: | James Posey, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Vanderbilt University Medical Center ) |
| Study ID Numbers: | 070433, R21CA123881 |
| Study First Received: | August 9, 2007 |
| Last Updated: | August 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00515216 |
| Health Authority: | United States: Institutional Review Board |
|
Phase II Gastric cancer Gastroesophageal cancer Metastatic |
FOLFOX Thymidylate synthase Pharmacogenomic |
|
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Stomach cancer Oxaliplatin Digestive System Diseases |
Stomach Diseases Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
|
Neoplasms Neoplasms by Site |
