TY - JOUR
T1 - Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma
T2 - A Gynecologic Oncology Group Study
AU - Miller, David Scott
AU - Blessing, John A.
AU - Waggoner, Steven
AU - Schilder, Jeanne
AU - Sorosky, Joel
AU - Bloss, Jeffrey
AU - Schilder, Russell
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 and Data Center (CA 37517). The following Gynecologic Oncology Group member institutions participated in this study: University of Alabama at Birmingham, Walter Reed Army Medical Center, University of California at Los Angeles, University of Pennsylvania Cancer Center, University of Cincinnati Medical Center, University of North Carolina, University of Iowa Hospitals and Clinics, University of Texas Southwestern Medical Center at Dallas, Indiana University Medical Center, Wake Forest University School of Medicine, University of California Medical Center at Irvine, Tufts-New England Medical Center, Rush-Presbyterian-St. Lukes Medical Center, State University of New York at Brooklyn, University of Kentucky, Community Clinical Oncology Program, The Cleveland Clinic Foundation, State University of New York at Stony Brook, Washington University School of Medicine, University of Massachusetts Medical School, Fox Chase Cancer Center, Medical University of South Carolina, University of Oklahoma, University of Virginia, University of Chicago, Case Western Reserve University, Tampa Bay Cancer Consortium, North Shore University Hospital, and Ellis Fischel Cancer Center.
PY - 2005/1
Y1 - 2005/1
N2 - To estimate the antitumor activity of 9-aminocamptothecin (9-AC) in patients with recurrent platinum-"resistant" ovarian cancer; and to determine the nature and degree of toxicity of 9-AC in this cohort of patients. A multicenter phase II study was conducted by the Gynecologic Oncology Group (GOG). Patients were to receive 9-AC (colloidal dispersion) 25 μg/m 2/h (600 μg/m 2/day) IV over 120 h (5 days) beginning days 1 and 8. Dose adjustment was permitted for toxicity. This schedule was repeated every 21 days until disease progression or unacceptable adverse events. Hematopoietic growth factor support was used as necessary. From January 1999 to December 2000, 29 member institutions of the GOG enrolled 58 patients. Two patients received no therapy; thus, 56 (97%) were evaluable. Median age was 61 (range: 33-81) years. A median of four (range: 1-32) courses of 9-AC was administered. The most frequent grade 3 or 4 toxicities were neutropenia in 46%, leukopenia in 37%, gastrointestinal in 29%, anemia in 25%, and thrombocytopenia in 21%. There was one possible treatment-related death. There were four (7%) complete and four (7%) partial responses, for an overall response rate of 14%. Eighteen (32%) patients had stable disease, 22 (39%) progressed, and response could not be assessed in 8 (14%). The 9-AC at this dose and schedule showed limited activity comparable to that seen with other agents in platinum-resistant ovarian or primary peritoneal cancer.
AB - To estimate the antitumor activity of 9-aminocamptothecin (9-AC) in patients with recurrent platinum-"resistant" ovarian cancer; and to determine the nature and degree of toxicity of 9-AC in this cohort of patients. A multicenter phase II study was conducted by the Gynecologic Oncology Group (GOG). Patients were to receive 9-AC (colloidal dispersion) 25 μg/m 2/h (600 μg/m 2/day) IV over 120 h (5 days) beginning days 1 and 8. Dose adjustment was permitted for toxicity. This schedule was repeated every 21 days until disease progression or unacceptable adverse events. Hematopoietic growth factor support was used as necessary. From January 1999 to December 2000, 29 member institutions of the GOG enrolled 58 patients. Two patients received no therapy; thus, 56 (97%) were evaluable. Median age was 61 (range: 33-81) years. A median of four (range: 1-32) courses of 9-AC was administered. The most frequent grade 3 or 4 toxicities were neutropenia in 46%, leukopenia in 37%, gastrointestinal in 29%, anemia in 25%, and thrombocytopenia in 21%. There was one possible treatment-related death. There were four (7%) complete and four (7%) partial responses, for an overall response rate of 14%. Eighteen (32%) patients had stable disease, 22 (39%) progressed, and response could not be assessed in 8 (14%). The 9-AC at this dose and schedule showed limited activity comparable to that seen with other agents in platinum-resistant ovarian or primary peritoneal cancer.
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U2 - 10.1016/j.ygyno.2004.09.015
DO - 10.1016/j.ygyno.2004.09.015
M3 - Article
C2 - 15589582
AN - SCOPUS:10044237834
SN - 0090-8258
VL - 96
SP - 67
EP - 71
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 1
ER -
