A phase II study of gefitinib, 5-fluorouracil, leucovorin, and oxaliplatin in previously untreated patients with metastatic colorectal cancer.

Abstract

PURPOSE:

We investigated the gefitinib, 5-fluorouracil (5-FU), leucovorin and oxaliplatin (IFOX) regimen as first-line therapy in patients with metastatic colorectal cancer.

EXPERIMENTAL DESIGN:

Eligible patients had stage IV colorectal adenocarcinoma, and had not received prior chemotherapy for metastatic disease. Each cycle consisted of 14 days. Cycle 1 consisted of oxaliplatin, leucovorin, and 5-FU (FOLFOX-4). All subsequent cycles consisted of FOLFOX-4 with gefitinib at 500 mg orally daily throughout the 14-day cycle.

RESULTS:

Forty-five patients were enrolled and were assessable for toxicity. Forty-three patients were assessable for response. Thirty-one of the 43 patients (72%) had either a complete or partial response by the Response Evaluation Criteria in Solid Tumors. Median overall survival was 20.5 months. Median time to progression was 9.3 months. Commonly encountered grade 3 or 4 toxicities included diarrhea in 67% of patients and neutropenia in 60%. Grade 2 acneiform skin rash typical of gefitinib occurred in 60% of patients.

CONCLUSIONS:

IFOX is an active first-line regimen in patients with metastatic colorectal adenocarcinoma, showing higher response rates but also increased toxicities compared with FOLFOX-4 alone in a similar patient population.

• Authors: George A Fisher, Timothy Kuo, Meghan Ramsey, Erich Schwartz, Robert V Rouse, Cheryl D Cho, Joanne Halsey, Branimir I Sikic
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 14 Issue 21 Pg. 7074-9 (Nov 01 2008) ISSN: 1078-0432 [Print] United States
• PMID: 18981005 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Quinazolines
• Oxaliplatin
• Leucovorin
• Gefitinib
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Colorectal Neoplasms (drug therapy)
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage)
• Gefitinib
• Humans
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin
• Quinazolines (administration & dosage)