A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: A Gynecologic Oncology Group study

Peter G. Rose, John A. Blessing, Harrison G. Ball, James Hoffman, David Warshal, Koenraad De Geest, David H. Moore

Research output: Contribution to journalArticle

130 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)130-135
Number of pages6
JournalGynecologic Oncology
Volume88
Issue number2
DOIs
StatePublished - Feb 1 2003
Externally publishedYes

Fingerprint

docetaxel
Paclitaxel
Carcinoma
Neutropenia
Platinum
Microtubules
Ovarian Neoplasms
Dexamethasone
Appointments and Schedules
Breast Neoplasms

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma : A Gynecologic Oncology Group study. / Rose, Peter G.; Blessing, John A.; Ball, Harrison G.; Hoffman, James; Warshal, David; De Geest, Koenraad; Moore, David H.

In: Gynecologic Oncology, Vol. 88, No. 2, 01.02.2003, p. 130-135.

Research output: Contribution to journalArticle

Rose, Peter G. ; Blessing, John A. ; Ball, Harrison G. ; Hoffman, James ; Warshal, David ; De Geest, Koenraad ; Moore, David H. / A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma : A Gynecologic Oncology Group study. In: Gynecologic Oncology. 2003 ; Vol. 88, No. 2. pp. 130-135.
@article{8ceb26c89dd4421785ed8147900d7f71,
title = "A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: A Gynecologic Oncology Group study",
abstract = "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.",
author = "Rose, {Peter G.} and Blessing, {John A.} and Ball, {Harrison G.} and James Hoffman and David Warshal and {De Geest}, Koenraad and Moore, {David H.}",
year = "2003",
month = "2",
day = "1",
doi = "10.1016/S0090-8258(02)00091-4",
language = "English (US)",
volume = "88",
pages = "130--135",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "2",

}

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 - De Geest, Koenraad

AU - Moore, David H.

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 -