A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer

Edwin A. Alvarez, Aaron Wolfson, Matt Pearson, Meredith P. Crisp, Luis E. Mendez, Nicholas C. Lambrou, Joseph A. Lucci

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objectives: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Methods: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m2, 30 mg/m2 and 40 mg/m2 given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Results: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m2 dose level consisting of colonic and ureteral obstruction. At the 30 mg/m2 dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m2 dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). Conclusions: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m2.

Original languageEnglish
Pages (from-to)195-199
Number of pages5
JournalGynecologic Oncology
Volume113
Issue number2
DOIs
StatePublished - May 1 2009

Fingerprint

docetaxel
Squamous Cell Neoplasms
Radio
Uterine Cervical Neoplasms
Maximum Tolerated Dose
Cervix Uteri
Squamous Cell Carcinoma
Radiotherapy
Ureteral Obstruction
Diarrhea
Pneumonia
Hypersensitivity
Therapeutics
Lymph Nodes

Keywords

  • Cervical cancer
  • Chemotherapy
  • Docetaxel
  • Phase I
  • Radiation therapy

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer. / Alvarez, Edwin A.; Wolfson, Aaron; Pearson, Matt; Crisp, Meredith P.; Mendez, Luis E.; Lambrou, Nicholas C.; Lucci, Joseph A.

In: Gynecologic Oncology, Vol. 113, No. 2, 01.05.2009, p. 195-199.

Research output: Contribution to journalArticle

Alvarez, Edwin A. ; Wolfson, Aaron ; Pearson, Matt ; Crisp, Meredith P. ; Mendez, Luis E. ; Lambrou, Nicholas C. ; Lucci, Joseph A. / A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer. In: Gynecologic Oncology. 2009 ; Vol. 113, No. 2. pp. 195-199.
@article{26cd757dce71499097aafa8061e9a67c,
title = "A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer",
abstract = "Objectives: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Methods: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m2, 30 mg/m2 and 40 mg/m2 given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Results: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m2 dose level consisting of colonic and ureteral obstruction. At the 30 mg/m2 dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m2 dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67{\%}) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67{\%}) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). Conclusions: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m2.",
keywords = "Cervical cancer, Chemotherapy, Docetaxel, Phase I, Radiation therapy",
author = "Alvarez, {Edwin A.} and Aaron Wolfson and Matt Pearson and Crisp, {Meredith P.} and Mendez, {Luis E.} and Lambrou, {Nicholas C.} and Lucci, {Joseph A.}",
year = "2009",
month = "5",
day = "1",
doi = "10.1016/j.ygyno.2008.12.033",
language = "English",
volume = "113",
pages = "195--199",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "2",

}

TY - JOUR

T1 - A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer

AU - Alvarez, Edwin A.

AU - Wolfson, Aaron

AU - Pearson, Matt

AU - Crisp, Meredith P.

AU - Mendez, Luis E.

AU - Lambrou, Nicholas C.

AU - Lucci, Joseph A.

PY - 2009/5/1

Y1 - 2009/5/1

N2 - Objectives: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Methods: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m2, 30 mg/m2 and 40 mg/m2 given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Results: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m2 dose level consisting of colonic and ureteral obstruction. At the 30 mg/m2 dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m2 dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). Conclusions: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m2.

AB - Objectives: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Methods: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m2, 30 mg/m2 and 40 mg/m2 given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Results: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m2 dose level consisting of colonic and ureteral obstruction. At the 30 mg/m2 dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m2 dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). Conclusions: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m2.

KW - Cervical cancer

KW - Chemotherapy

KW - Docetaxel

KW - Phase I

KW - Radiation therapy

UR - http://www.scopus.com/inward/record.url?scp=63749107733&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=63749107733&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2008.12.033

DO - 10.1016/j.ygyno.2008.12.033

M3 - Article

VL - 113

SP - 195

EP - 199

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 2

ER -