Phase I study of gefitinib, oxaliplatin, 5-fluorouracil, and leucovorin (IFOX) in patients with advanced solid malignancies |
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Authors: | Cheryl D. Cho George A. Fisher Joanne Halsey Dr. Branimir I. Sikic |
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Affiliation: | (1) Oncology Division, Department of Medicine, Stanford University School of Medicine, Stanford, CA, 94305;(2) Oncology Division, Stanford University Medical Center, 269 Campus Drive, CCSR-1105, Stanford, CA, 94305-5151 |
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Abstract: | Summary Purpose: Aphase 1 study of gefitinib in combination with oxaliplatin, 5-fluorouracil and leucovorin (IFOX)was conducted to evaluate the safety and feasibility of this regimen. Patients and Methods: Patients with advanced solid malignancies were treated with escalating doses of gefitinib (250 mg or 500 mg once daily) in combination with FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin). The initial dose of oxaliplatin was 70 mg/m2 with sequential dose escalation to 85 mg/m2. Results: Sixteen patients received a total of 138 14-day courses of daily gefitinib in combination with FOLFOX. Escalation of gefitinib from 250 mg/d to 500 mg/d with FOLFOX was well-tolerated. In addition, no severe toxicities precluded subsequent dose escalation of oxaliplatin from 70 mg/m2 to 85 mg/m2 at which no dose-limiting toxicity was seen. No further dose escalation was performed as this represented the oxaliplatin dose administered in the standard FOLFOX-4 regimen. The most predominant toxicity was diarrhea, which was well controlled with oral antidiarrheal agents. Four partial remissions occurred in patients with metastatic colorectal cancer. Conclusions: Gefitinib as a 500 mg daily continuous dose was well tolerated in combination with full doses of FOLFOX-4. |
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Keywords: | iressa gefitinib oxaliplatin 5-fluorouracil leucovorin phase 1 study |
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