At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Docetaxel, 5-Fluorouracil and Oxaliplatin (D-FOX) in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction
In Brief
A Phase 2 clinical trial evaluating 5-Fluorouracil, Docetaxel, and 1 other intervention for Gastrointestinal Diseases. Completed, enrolled 98 participants across 1 site.
Detailed Summary
Phase I Objectives Primary: 1\. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). Secondary: 1\. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination. Phase II Objectives Primary: 1\. To assess time to cancer progression to D-FOX treatment regimen. Secondary: 1. To assess response rate to D-FOX treatment regimen. 2. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen. 3. Determine overall survival. 4. Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.
Study Details
Timeline
Interventions
2.2 Gm/m\^2 IV over 48 hours on Day 1.
20 mg/m\^2 IV over 60 minutes
85 mg/m\^2 IV over 120 minutes on Day 1.