TY - JOUR
T1 - A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma
T2 - A Gynecologic Oncology Group study
AU - Rose, Peter G.
AU - Blessing, John A.
AU - Ball, Harrison G.
AU - Hoffman, James
AU - Warshal, David
AU - DeGeest, Koen
AU - Moore, David H.
N1 - Funding Information:
This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517). The following Gynecologic Oncology Group institutions participated in this study: The University of Alabama at Birmingham, Duke University Medical Center, Abington Memorial Hospital, Wayne State University, University of Minnesota Medical School, Emory University Clinic, University of Mississippi Medical Center, University of California at Los Angeles, University of Pennsylvania Cancer Center, Milton S. Hershey Medical Center, University of Cincinnati, University of Iowa Hospitals and Clinics, Indiana University Medical Center, Tufts-New England Medical Center, Rush-Presbyterian-St. Luke’s Medical Center, SUNY Downstate Medical Center, Community Clinical Oncology Program, Washington University School of Medicine, Cooper Hospital/University Medical Center, Columbus Cancer Council, University of Massachusetts Medical Center, University of Oklahoma, University of Virginia, University of Chicago, Tacoma General Hospital, Thomas Jefferson University Hospital. Case Western Reserve University. Brookview Research, Inc., and Ellis Fischel Cancer Center.
PY - 2003/2/1
Y1 - 2003/2/1
N2 - Objectives. Docetaxel is an inhibitor of microtubule depolymerization and has demonstrated activity in paclitaxel-resistant breast cancer and gynecologic cancer. The Gynecologic Oncology Group (GOG) conducted a study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma to determine its activity, and nature and degree of toxicity, in this cohort of patients. Methods. Patients with platinum- and paclitaxel-resistant ovarian or peritoneal carcinoma, defined as progression while on or within 6 months of therapy, were eligible if they had measurable disease and had not received more than one chemotherapy regimen. Docetaxel at a dose of 100 mg/m2 was administered iv over 1 h every 21 days. A prophylactic regimen of oral dexamethasone 8 mg bid was begun 24 h before docetaxel administration and continued for 48 h thereafter. Hepatic function was strictly monitored. Results. Sixty patients were entered and treated with a total of 256 courses, with all 60 evaluable for toxicity and 58 evaluable for response. Responses were observed in 22.4% of patients, with 5.2% achieving complete response and 17.2% achieving partial response (95% CI, 12.5-35.3%). The median duration of response was 2.5 months. The likelihood of observing a response did not appear to be related to the length of the prior paclitaxel-free interval or duration of prior paclitaxel infusions. The principal adverse effect of grade 4 neutropenia occurred in 75% of patients. There was one treatment-related death. Dose reductions were required in 36% of patients. Conclusions. Docetaxel is active in paclitaxel-resistant ovarian and peritoneal cancer but, in view of significant hematologic toxicity, further study is warranted to ascertain its optimal dose and schedule.
AB - Objectives. Docetaxel is an inhibitor of microtubule depolymerization and has demonstrated activity in paclitaxel-resistant breast cancer and gynecologic cancer. The Gynecologic Oncology Group (GOG) conducted a study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma to determine its activity, and nature and degree of toxicity, in this cohort of patients. Methods. Patients with platinum- and paclitaxel-resistant ovarian or peritoneal carcinoma, defined as progression while on or within 6 months of therapy, were eligible if they had measurable disease and had not received more than one chemotherapy regimen. Docetaxel at a dose of 100 mg/m2 was administered iv over 1 h every 21 days. A prophylactic regimen of oral dexamethasone 8 mg bid was begun 24 h before docetaxel administration and continued for 48 h thereafter. Hepatic function was strictly monitored. Results. Sixty patients were entered and treated with a total of 256 courses, with all 60 evaluable for toxicity and 58 evaluable for response. Responses were observed in 22.4% of patients, with 5.2% achieving complete response and 17.2% achieving partial response (95% CI, 12.5-35.3%). The median duration of response was 2.5 months. The likelihood of observing a response did not appear to be related to the length of the prior paclitaxel-free interval or duration of prior paclitaxel infusions. The principal adverse effect of grade 4 neutropenia occurred in 75% of patients. There was one treatment-related death. Dose reductions were required in 36% of patients. Conclusions. Docetaxel is active in paclitaxel-resistant ovarian and peritoneal cancer but, in view of significant hematologic toxicity, further study is warranted to ascertain its optimal dose and schedule.
UR - http://www.scopus.com/inward/record.url?scp=0037331627&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0037331627&partnerID=8YFLogxK
U2 - 10.1016/S0090-8258(02)00091-4
DO - 10.1016/S0090-8258(02)00091-4
M3 - Article
C2 - 12586591
AN - SCOPUS:0037331627
VL - 88
SP - 130
EP - 135
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 2
ER -