A Phase II study of acute toxicity for Celebrex{sup TM} (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: Primary endpoint analysis of RTOG 0128
- Department of Radiation Oncology, Huntsman Cancer Hospital, University of Utah, Salt Lake City, UT (United States)
- Statistical Department, Radiation Therapy Oncology Group, Philadelphia, PA (United States)
- Bodine Center for Cancer Treatment, Thomas Jefferson University Hospital, Philadelphia, PA (United States)
- Department of Obstetrics and Gynecology, Wake Forest University School of Medicine, Winston-Salem, NC (United States)
- Department of Radiation Oncology, University of Texas, M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Radiation Oncology, University of CA Davis Cancer Center, Davis, CA (United States)
- Department of Radiation Oncology, LDS Hospital Radiation Center, Salt Lake City, UT (United States)
- Akron General Medical Center, Akron Radiation Oncology Associates Inc., Akron OH (United States)
- Department of Radiation Oncology, Wake Forest University School of Medicine, Winston-Salem, NC (United States)
Purpose: To determine treatment-related acute toxicity rates in patients with locally advanced cervical cancer treated by oral celecoxib, i.v. cisplatin and 5-FU, and concurrent pelvic radiation therapy. Methods and Materials: Eligible patients on this RTOG Phase I-II study for advanced cervix cancer included FIGO Stage IIB-IVA or patients with FIGO Stage IB through IIA with biopsy proven pelvic node metastases or tumor size {>=}5 cm. Patients were treated with pelvic radiotherapy and brachytherapy. Celecoxib was prescribed at 400 mg twice daily beginning on day 1 for 1 year. Cisplatin (75 mg/m2) and 5-FU (1g/m2 for 4 days) were administered every 3 weeks times 3. The primary end point of the study was treatment related toxicity. Results: Between August 2001 and March 2004, 84 patients were accrued to the study and 77 patients were evaluable for toxicity. Regarding the primary end point, toxicities were observed in the following areas: blood/bone marrow (16), gastrointestinal (14), pain (7), renal/genitourinary (6), cardiovascular (3), hemorrhage (1), and neurologic (1). For the first 75 evaluable patients, a toxicity failure was identified in 36 patients for a rate of 48%. Conclusions: Celecoxib at 400 mg twice daily together with concurrent cisplatin and 5-FU and pelvic radiotherapy has a high incidence of acute toxicities. The most frequent toxicities were hematologic. Albeit, the toxicity was deemed excessive in this trial, the rate of toxicities was not too different compared to other recent experiences with concurrent chemoradiation for advanced cervix cancer.
- OSTI ID:
- 20850301
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 67, Issue 1; Other Information: DOI: 10.1016/j.ijrobp.2006.08.002; PII: S0360-3016(06)02756-8; Copyright (c) 2007 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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