Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

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.

Timeline

Start

2004-08

Primary completion

2015-06

Completion

2015-06

Publications

• Results Blum Murphy MA, Qiao W, Mewada N, Wadhwa R, Elimova E, Takashi T, Ho L, Phan A, Baker J, Ajani J. A Phase I/II Study of Docetaxel, Oxaliplatin, and Fluorouracil (D-FOX) Chemotherapy in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction. Am J Clin Oncol. 2018 Apr;41(4):321-325. doi: 10.1097/COC.0000000000000271.

Drugs

Indications