title: A Phase II study of acute toxicity for Celebrex (celecoxib) and chemoradiation in patients with locally advanced cervical cancer: primary endpoint analysis of RTOG 0128.
abstract: OBJECTIVE
  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
  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 > or =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.
authors.affiliation: Department of Radiation Oncology, Huntsman Cancer Hospital, University of Utah, Salt Lake City, UT 84132, USA. david.gaffney@hci.utah.edu
authors.forename: David K
authors.initials: DK
authors.lastname: Gaffney
authors.forename: Kathryn
authors.initials: K
authors.lastname: Winter
authors.forename: Adam P
authors.initials: AP
authors.lastname: Dicker
authors.forename: Brigitte
authors.initials: B
authors.lastname: Miller
authors.forename: Patricia J
authors.initials: PJ
authors.lastname: Eifel
authors.forename: Janice
authors.initials: J
authors.lastname: Ryu
authors.forename: Vilija
authors.initials: V
authors.lastname: Avizonis
authors.forename: Mitch
authors.initials: M
authors.lastname: Fromm
authors.forename: Kathryn
authors.initials: K
authors.lastname: Greven
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001918:Brachytherapy / Q000379:methods; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000532:radiotherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D000068579:Celecoxib; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009367:Neoplasm Staging; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D002945:Cisplatin; D005472:Fluorouracil