FCCC LOGO Faculty Publications
McMeekin DS , Walker JL , Hartenbach EM , Bookman MA , Koh WJ
Phase I trial of the treatment of high-risk endometrial cancer with concurrent weekly paclitaxel and cisplatin and whole abdominal radiation therapy: A Gynecologic Oncology Group study
Gynecologic Oncology. 2008 Jan;112(1) :134-141
PMID: ISI:000262588100024   
Back to previous list
Objectives. To determine the maximum tolerated dose (MTD) and feasibility of weekly cisplatin and paclitaxel chemotherapy administered concurrently with whole abdominal radiation therapy (WART) in women with high-risk endometrial cancer. Methods. Following surgery, patients with stage III-IV endometrial cancer (any histology) or with stage I-II serous or clear cell histology, and with largest residual disease <= 2 cm were eligible for this phase I feasibility trial. Six weekly cycles of chemotherapy were administered with WART in dose level (DL) cohorts of 3 patients in a 3 + 3 design. Once the MTD was defined, a second, feasibility portion of the trial was conducted to assess for chronic toxicity. All patients were to be treated with 25 Gy to the abdomen and 50.2 Gy to the pelvis. Results. Thirty-five patients were enrolled in the study, including 21 in the dose finding portion, and 14 in the feasibility portion of the trial. The initial DL tested was paclitaxel 10 mg/m(2) and cisplatin 20 mg/m(2). The MTD identified was at DL3 using paclitaxel 20 mg/m(2) and cisplatin 25 mg/m(2). The most common acute dose-limiting toxicities (DLT) were gastrointestinal and hematologic. The prescribed radiation therapy was successfully delivered to 32/35 patients. Twenty patients (6 phase 1, 14 feasibility) were assessed at the MTD. No acute grade 4 toxicities, and two grade 3-4 chronic toxicities were observed in these patients. Treatment contributed to the deaths of 2 patients. Conclusion. A regimen of cisplatin 25 mg/m(2) and paclitaxel 20 mg/m(2) weekly with WART was determined to be feasible, but is associated with moderate acute and chronic gastrointestinal toxicity. (c) 2008 Elsevier Inc. All rights reserved.
ISI Document Delivery No.: 396JN Times Cited: 0 Cited Reference Count: 22 Cited References: BALL HG, 1996, GYNECOL ONCOL, V62, P278 CHEN MD, 1997, GYNECOL ONCOL, V67, P131 CHOY H, 1993, CANCER, V71, P3774 DISILVESTRO PA, 2006, GYNECOL ONCOL, V103, P1038, DOI 10.1016/j.ygyno.2006.06.017 FRIGERIO L, 2001, GYNECOL ONCOL, V81, P53 GIBBONS S, 1991, INT J RADIAT ONCOL, V21, P1019 GREER B, 1993, GYNECOL ONCOL, V16, P365 KEYS HM, 1999, NEW ENGL J MED, V340, P1154 LIAN JD, 2008, INT J RADIAT ONCOL, V70, P935, DOI 10.1016/j.ijrobp.2007.10.021 LINCOLN S, 2003, GYNECOL ONCOL, V88, P277, DOI 10.1016/S0090-8258(02)00068-9 MALFETANO J, 1993, CANCER, V71, P3703 MARTINEZ AA, 2003, GYNECOL ONCOL, V90, P537, DOI 10.1016/S0090-8258(03)00199-9 MORRIS M, 1999, NEW ENGL J MED, V340, P1137 RANDALL ME, 2006, J CLIN ONCOL, V24, P36, DOI 10.1200/JCO.2004.00.7617 REISINGER SA, 1996, GYNECOL ONCOL, V63, P299 ROSE PG, 1999, NEW ENGL J MED, V340, P1144 SOPER JT, 2004, GYNECOL ONCOL, V95, P95, DOI 10.1016/j.ygyno.2004.06.041 SUTTON G, 2005, GYNECOL ONCOL, V97, P755, DOI 10.1016/j.ygyno.2005.03.011 SUTTON G, 2006, GYNECOL ONCOL, V100, P349, DOI 10.1016/j.ygyno.2005.08.037 TISHLER RB, 1992, INT J RADIAT ONCOL, V22, P613 TWIGGS LB, 1986, GYNECOL ONCOL, V24, P143 VOGT H, 1997, SEMINAR ONCOL, V24 McMeekin, D. Scott Walker, Joan L. Hartenbach, Ellen M. Bookman, Michael A. Koh, Wui-Jin ACADEMIC PRESS INC ELSEVIER SCIENCE; 525 B ST, STE 1900, SAN DIEGO, CA 92101-4495 USA