Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.