CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
fluorouracil +6 moredrug
Likely dose
oxaliplatin 500 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00514020
NCT00514020Phase 2Completed
CompareCT.gov

Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study

Vanderbilt-Ingram Cancer Center·interventional·Posted Aug 9, 2007·Updated Nov 1, 2012

In Brief

A Phase 2 clinical trial evaluating fluorouracil, leucovorin calcium, and 5 other interventions for Gastric Cancer. Completed, enrolled 33 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2007
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.9 years ago

Interventions

fluorouracildrug

Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.

leucovorin calciumdrug

through a vein over 2 hours on days 1 and 15.

oxaliplatindrug

500 ml D5W through a vein over 2 hours on days 1 and 15.

gene expression analysisgenetic

Blood collection

polymorphism analysisgenetic

Blood collection

protein expression analysisgenetic

Blood collection

pharmacological studyother

Blood collection