Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma: A Gynecologic Oncology Group Study

David Scott Miller, John A. Blessing, Steven Waggoner, Jeanne Schilder, Joel Sorosky, Jeffrey Bloss, Russell Schilder

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)67-71
Number of pages5
JournalGynecologic Oncology
Volume96
Issue number1
DOIs
StatePublished - Jan 2005

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9-aminocamptothecin
Platinum
Carcinoma
Appointments and Schedules
Leukopenia
Neutropenia
Thrombocytopenia
Ovarian Neoplasms
Disease Progression
Anemia
Intercellular Signaling Peptides and Proteins

Keywords

  • 9-Aminocamptothecin
  • Ovarian cancer
  • Primary peritoneal carcinoma

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma : A Gynecologic Oncology Group Study. / Miller, David Scott; Blessing, John A.; Waggoner, Steven; Schilder, Jeanne; Sorosky, Joel; Bloss, Jeffrey; Schilder, Russell.

In: Gynecologic Oncology, Vol. 96, No. 1, 01.2005, p. 67-71.

Research output: Contribution to journalArticle

Miller, David Scott ; Blessing, John A. ; Waggoner, Steven ; Schilder, Jeanne ; Sorosky, Joel ; Bloss, Jeffrey ; Schilder, Russell. / Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma : A Gynecologic Oncology Group Study. In: Gynecologic Oncology. 2005 ; Vol. 96, No. 1. pp. 67-71.
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