Phase II clinical trial of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant ovarian or primary peritoneal cancer

A Gynecologic Oncology Group study

Koenraad De Geest, John A. Blessing, Robert T. Morris, S. Diane Yamada, Bradley J. Monk, Susan L. Zweizig, Daniela Matei, Carolyn Y. Muller, William E. Richards

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Purpose: Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma. Patients and Methods: Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m 2 administered over 1 hour on days 1, 8, and 15 of a 28-day cycle. Results: Of 51 patients entered, 49 were eligible. The objective response rate was 14.3% (95% CI, 5.9% to 27.2%), with three complete and four partial responses. Twenty patients (40.8%) had stable disease, whereas sixteen (32.7%) had increasing disease. The median time to progression was 4.4 months (95% CI, 0.8 to 32.6+ months); median survival was 14.8 months (95% CI, 0.8 to 50.0) months. Patients received a median of two treatment cycles (range, 1 to 29 cycles), and 18.4% of patients received ≥ six cycles. Adverse effects included peripheral grade 2 (28.5%) and grade 3 (6.1%) neuropathy, grades 3 to 4 neutropenia (20.4%), grade 3 fatigue (14.3%), grade 3 nausea/emesis (22%), grade 3 diarrhea (10%), and grade 3 mucositis (4%). Conclusion: Ixabepilone 20 mg/m2 over 1 hour on days 1, 8, and 15 of a 28-day cycle demonstrates antitumor activity and acceptable safety in patients with platinum- and taxane-resistant recurrent or persistent ovarian or primary peritoneal carcinoma.

Original languageEnglish (US)
Pages (from-to)149-153
Number of pages5
JournalJournal of Clinical Oncology
Volume28
Issue number1
DOIs
StatePublished - Jan 1 2010
Externally publishedYes

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Phase II Clinical Trials
Platinum
Neoplasms
Carcinoma
Mucositis
Patient Safety
ixabepilone
taxane
Neutropenia
Microtubules
Nausea
Vomiting
Fatigue
Diarrhea
Breast Neoplasms
Safety
Survival
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Phase II clinical trial of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant ovarian or primary peritoneal cancer : A Gynecologic Oncology Group study. / De Geest, Koenraad; Blessing, John A.; Morris, Robert T.; Yamada, S. Diane; Monk, Bradley J.; Zweizig, Susan L.; Matei, Daniela; Muller, Carolyn Y.; Richards, William E.

In: Journal of Clinical Oncology, Vol. 28, No. 1, 01.01.2010, p. 149-153.

Research output: Contribution to journalArticle

De Geest, Koenraad ; Blessing, John A. ; Morris, Robert T. ; Yamada, S. Diane ; Monk, Bradley J. ; Zweizig, Susan L. ; Matei, Daniela ; Muller, Carolyn Y. ; Richards, William E. / Phase II clinical trial of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant ovarian or primary peritoneal cancer : A Gynecologic Oncology Group study. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 1. pp. 149-153.
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abstract = "Purpose: Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma. Patients and Methods: Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m 2 administered over 1 hour on days 1, 8, and 15 of a 28-day cycle. Results: Of 51 patients entered, 49 were eligible. The objective response rate was 14.3{\%} (95{\%} CI, 5.9{\%} to 27.2{\%}), with three complete and four partial responses. Twenty patients (40.8{\%}) had stable disease, whereas sixteen (32.7{\%}) had increasing disease. The median time to progression was 4.4 months (95{\%} CI, 0.8 to 32.6+ months); median survival was 14.8 months (95{\%} CI, 0.8 to 50.0) months. Patients received a median of two treatment cycles (range, 1 to 29 cycles), and 18.4{\%} of patients received ≥ six cycles. Adverse effects included peripheral grade 2 (28.5{\%}) and grade 3 (6.1{\%}) neuropathy, grades 3 to 4 neutropenia (20.4{\%}), grade 3 fatigue (14.3{\%}), grade 3 nausea/emesis (22{\%}), grade 3 diarrhea (10{\%}), and grade 3 mucositis (4{\%}). Conclusion: Ixabepilone 20 mg/m2 over 1 hour on days 1, 8, and 15 of a 28-day cycle demonstrates antitumor activity and acceptable safety in patients with platinum- and taxane-resistant recurrent or persistent ovarian or primary peritoneal carcinoma.",
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AU - Blessing, John A.

AU - Morris, Robert T.

AU - Yamada, S. Diane

AU - Monk, Bradley J.

AU - Zweizig, Susan L.

AU - Matei, Daniela

AU - Muller, Carolyn Y.

AU - Richards, William E.

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