Phase I-II Trial of Cetuximab, Capecitabine, Oxaliplatin, and Radiotherapy as Preoperative Treatment in Rectal Cancer
- Department of Radiation Therapy, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen (Germany)
- Department of Haematology and Oncology, Martin-Luther-University Halle-Wittenberg, Sachsen-Anhalt (Germany)
- Department of Radiotherapy, University of Regensburg, Regensburg (Germany)
- Department of General Surgery, Georg-August University of Goettingen, Goettingen (Germany)
- Department of Radiotherapy, Martin-Luther-University Halle-Wittenberg, Sachsen-Anhalt (Germany)
- Department of General Surgery, University of Regensburg, Regensburg (Germany)
- Department of Radiation Oncology and Radiotherapy, Georg-August University of Goettingen, Goettingen (Germany)
- Third Department of Internal Medicine, Division of Hematology/Medical Oncology, Klinikum Rechts der Isar, Technical University of Munich, Munich (Germany)
- WiSP Research Institute, Langenfeld (Germany)
- Department of Surgery, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen (Germany)
Purpose: To evaluate the safety and activity of preoperative radiotherapy (RT) with concurrent cetuximab, capecitabine, and oxaliplatin in rectal cancer patients. Patients and Methods: A total of 60 patients with rectal cancer (T3-T4 or N+, M1 allowed) entered the trial at five investigator sites; the data from 58 patients were assessable. Cetuximab was given as an initial dose of 400 mg/m{sup 2} 7 days before the start of RT, and then at 250 mg/m{sup 2} once weekly during RT (50.4 Gy in 28 fractions). Capecitabine and oxaliplatin were administered according to an established schedule of oxaliplatin (50 mg/m{sup 2} on Days 1, 8, 22, and 29) and capecitabine (Days 1-14 and 22-35) at three dose levels: 1,000, 1,300, and 1,650 mg/m{sup 2}/d during the Phase I part of the study. The main endpoint of the Phase II was the pathologic complete response rate. Results: Thirteen patients were included in the Phase I part of the study, and the maximal tolerated dose was not reached. Overall, 48 patients were treated at the recommended dose of capecitabine (1,650 mg/m{sup 2}) and 45 patients (94%) underwent surgery. A pathologic complete response was observed in 4 patients (9%), and moderate (n = 12), minimal (n = 10), and no tumor regression (n = 2) was noted in 24 (53%) of 45 patients. The mean radiation dose intensity, cetuximab, capecitabine, oxaliplatin was 98%, 95%, 94%, and 94%, respectively. The incidence of Grade 3-4 diarrhea was restricted to 19%. Postoperative complications of any grade occurred in 33% of patients. Conclusions: The results of our study have shown that cetuximab can be combined safely with capecitabine and oxaliplatin plus RT. The low pathologic complete response rate achieved should stimulate additional preclinical investigations to establish the best sequence of triple combinations.
- OSTI ID:
- 21039828
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 70, Issue 4; Other Information: DOI: 10.1016/j.ijrobp.2007.07.2356; PII: S0360-3016(07)03779-0; Copyright (c) 2008 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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