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

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

Research output: Contribution to journalArticle

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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 (US)
Pages (from-to)195-199
Number of pages5
JournalGynecologic Oncology
Volume113
Issue number2
DOIs
StatePublished - May 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

Alvarez, E. A., Wolfson, A. H., Pearson, J. M., Crisp, M. P., Mendez, L. E., Lambrou, N. C., & Lucci, J. A. (2009). A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer. Gynecologic Oncology, 113(2), 195-199. https://doi.org/10.1016/j.ygyno.2008.12.033

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

In: Gynecologic Oncology, Vol. 113, No. 2, 05.2009, p. 195-199.

Research output: Contribution to journalArticle

Alvarez, EA, Wolfson, AH, Pearson, JM, Crisp, MP, Mendez, LE, Lambrou, NC & Lucci, JA 2009, 'A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer', Gynecologic Oncology, vol. 113, no. 2, pp. 195-199. https://doi.org/10.1016/j.ygyno.2008.12.033
Alvarez, Edwin A. ; Wolfson, Aaron H. ; Pearson, J. 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.
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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.",
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