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Journal of Clinical Oncology, Vol 23, No 24 (August 20), 2005: pp. 5660-5667
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.17.376
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Phase II Multi-Institutional Randomized Trial of Docetaxel Plus Cisplatin With or Without Fluorouracil in Patients With Untreated, Advanced Gastric, or Gastroesophageal Adenocarcinoma

Jaffer A. Ajani, Miguel B. Fodor, Sergei A. Tjulandin, Vladimir M. Moiseyenko, Yee Chao, Sebastiao Cabral Filho, Alejandro Majlis, Sylvie Assadourian, Eric Van Cutsem

From the M.D. Anderson Cancer Center, Houston, TX; Hospital Clinico Universidad de Chile; Fundación Arturo López Pérez, Santiago, Chile; N.N. Blokhin Cancer Research Center, Moscow; N.N. Petrov Research Institute of Oncology, St Petersburg, Russia; Veterans General Hospital, Taipei, Taiwan; Santa Casa de Belo Horizonte, Belo Horizonte, Brazil; sanofi-aventis, Antony, France; and Leuven University Hospital, Leuven, Belgium

Address reprint requests to Jaffer A. Ajani, MD, Department of Gastrointestinal Medical Oncology, University of Texas M.D. Anderson Cancer Center, Box 426, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: jajani{at}mdanderson.org

PURPOSE: The purpose of this study was to define the contribution of docetaxel to combination chemotherapy in the outcome of patients with advanced gastric or gastroesophageal adenocarcinoma. We compared the overall response rate (ORR) and safety of docetaxel plus cisplatin (DC) with DC plus fluorouracil (DCF) to select either DC or DCF as the experimental treatment in the ensuing phase III part of trial V-325.

PATIENTS AND METHODS: In this phase II randomized study, untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received either DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2/d as continuous infusion on days 1 to 5) or DC (docetaxel 85 mg/m2 and cisplatin 75 mg/m2 on day 1) every 3 weeks. An independent data monitoring committee (IDMC) was to select one of the two regimens based primarily on ORR and safety profile.

RESULTS: Of 158 randomly assigned patients, 155 (DCF, n = 79; DC, n = 76) received treatment. The confirmed ORR was 43% for DCF (n = 79) and 26% for DC (n = 76). Median time to progression was 5.9 months for DCF and 5.0 months for DC. Median overall survival time was 9.6 months for DCF and 10.5 months for DC. The most frequent grade 3 and 4 events per patient included neutropenia (DCF = 86%; DC = 87%) and GI (DCF = 56%; DC = 30%).

CONCLUSION: Both regimens were active, but DCF produced a higher confirmed ORR than DC. Toxicity profiles of DCF were considered manageable. The IDMC chose DCF for the phase III part of V-325, which compares DCF with cisplatin plus fluorouracil.

Supported by Aventis Pharmaceuticals, a member of the sanofi-aventis Group.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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