A Phase I/II Study of Xyotax (CT-2103), A Tumor-Targeted Taxane, in Patients With Recurrent Ovarian Cancer

2.50
Hdl Handle:
http://hdl.handle.net/10755/165417
Category:
Abstract
Type:
Presentation
Title:
A Phase I/II Study of Xyotax (CT-2103), A Tumor-Targeted Taxane, in Patients With Recurrent Ovarian Cancer
Author(s):
Graham, C.; Sabbatini, P.; Brown, J.; Bolton, M.
Author Details:
C. Graham, Gynecologic Oncology Associates, Newport Beach, California, USA; P. Sabbatini; J. Brown; M. Bolton
Abstract:
Xyotax is a novel taxane designed to concentrate selectively in tumors and result in superior efficacy, safety, and symptom control compared to standard taxane therapy. Conjugation of paclitaxel to poly-L-glutamate (a chain of a naturally occurring amino acids) enhances aqueous solubility and eliminates the need for the toxic solubilizing agent Cremophor. Xyotax was evaluated in a multicenter phase I/II study of patients with heavily pretreated recurrent ovarian cancer; this study is now closed to enrollment. Ninety-nine patients received 1 to 11 cycles of Xyotax, each cycle administered as a 10-minute infusion, via a peripheral vein, at a dose of 175 mg/m2 conjugated paclitaxel every 21 days. 42% of patients received less than or equal to 4 cycles. Twelve patients remain on the study. The median number of prior regimens is 3 (range, 1–10). The data available to date are: PR in 9 patients, SD in 35 patients, and PD in 44 patients. As of July 2002, the 6-month survival rate was 92%. No baldness has been observed, and only 4 patients have developed mild hair thinning. Hypersensitivity reactions (HSRs), which occurred in only 10% of patients, were easily managed with steroid/antihistamine therapy. Many of these patients continued to receive additional cycles of the study drug with premedications to prevent recurrent HSRs. Only 2 patients discontinued the study due to HSRs. The routine use of steroid, antihistamine, and antiemetic premedications is not required in most patients. Almost all reported adverse events have been mild to moderate. Grade 3 (severe) drug-related events reported to date are leukopenia, neutropenia, neuropathy (4 patients each), HSRs (2 patients), and fatigue (1 patient). No drug-related grade 4 events have been reported. Response rates and times to progression for patients with platinum-resistant and platinum-sensitive disease will be presented separately. The promising activity and good tolerability of Xyotax seen in these heavily pretreated patients has prompted CTI to initiate a phase III trial of Xyotax for the first-line treatment of ovarian cancer.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2003
Conference Name:
28th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Denver, Colorado, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleA Phase I/II Study of Xyotax (CT-2103), A Tumor-Targeted Taxane, in Patients With Recurrent Ovarian Canceren_GB
dc.contributor.authorGraham, C.en_US
dc.contributor.authorSabbatini, P.en_US
dc.contributor.authorBrown, J.en_US
dc.contributor.authorBolton, M.en_US
dc.author.detailsC. Graham, Gynecologic Oncology Associates, Newport Beach, California, USA; P. Sabbatini; J. Brown; M. Boltonen_US
dc.identifier.urihttp://hdl.handle.net/10755/165417-
dc.description.abstractXyotax is a novel taxane designed to concentrate selectively in tumors and result in superior efficacy, safety, and symptom control compared to standard taxane therapy. Conjugation of paclitaxel to poly-L-glutamate (a chain of a naturally occurring amino acids) enhances aqueous solubility and eliminates the need for the toxic solubilizing agent Cremophor. Xyotax was evaluated in a multicenter phase I/II study of patients with heavily pretreated recurrent ovarian cancer; this study is now closed to enrollment. Ninety-nine patients received 1 to 11 cycles of Xyotax, each cycle administered as a 10-minute infusion, via a peripheral vein, at a dose of 175 mg/m2 conjugated paclitaxel every 21 days. 42% of patients received less than or equal to 4 cycles. Twelve patients remain on the study. The median number of prior regimens is 3 (range, 1–10). The data available to date are: PR in 9 patients, SD in 35 patients, and PD in 44 patients. As of July 2002, the 6-month survival rate was 92%. No baldness has been observed, and only 4 patients have developed mild hair thinning. Hypersensitivity reactions (HSRs), which occurred in only 10% of patients, were easily managed with steroid/antihistamine therapy. Many of these patients continued to receive additional cycles of the study drug with premedications to prevent recurrent HSRs. Only 2 patients discontinued the study due to HSRs. The routine use of steroid, antihistamine, and antiemetic premedications is not required in most patients. Almost all reported adverse events have been mild to moderate. Grade 3 (severe) drug-related events reported to date are leukopenia, neutropenia, neuropathy (4 patients each), HSRs (2 patients), and fatigue (1 patient). No drug-related grade 4 events have been reported. Response rates and times to progression for patients with platinum-resistant and platinum-sensitive disease will be presented separately. The promising activity and good tolerability of Xyotax seen in these heavily pretreated patients has prompted CTI to initiate a phase III trial of Xyotax for the first-line treatment of ovarian cancer.en_GB
dc.date.available2011-10-27T12:18:10Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:18:10Z-
dc.conference.date2003en_US
dc.conference.name28th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationDenver, Colorado, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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