A Phase II trial of edatrexate in patients with advanced renal cell carcinoma

An Eastern Cooperative Oncology Group Study

Robert Dreicer, Kathleen J. Propert, Timothy Kuzel, John M. Kirkwood, Peter J. O'Dwyer, Patrick Loehrer

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

We performed a Phase II trial of edatrexate in 44 chemotherapy-naive patients with advanced renal cell carcinoma. Prior therapy with one biological-response modifier was permitted. Most patients had multiple sites of metastatic disease and were considered to have a poor prognosis using Eastern Cooperative Oncology Group criteria. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly with 5 weeks of therapy considered one cycle. Oral cryotherapy using ice chips was administered before each edatrexate dose. Thirty-seven patients were eligible and evaluable for toxicity and response. Two patients obtained a partial response, for an overall response rate of 5.4% (95% confidence interval of 0.6%, 18.2%); one patient remained in remission at 26+ months. Three treatment-related deaths occurred. Toxicity was severe, with stomatitis, myelosuppression, and other gastrointestinal side effects most prominent. Edatrexate in this dose and schedule has minimal activity in advanced renal cell carcinoma and is toxic.

Original languageEnglish
Pages (from-to)251-253
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume20
Issue number3
DOIs
StatePublished - Jun 1997

Fingerprint

Renal Cell Carcinoma
Stomatitis
Cryotherapy
Poisons
Immunologic Factors
Ice
Appointments and Schedules
Therapeutics
edatrexate
Confidence Intervals
Drug Therapy

Keywords

  • Edatrexate
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A Phase II trial of edatrexate in patients with advanced renal cell carcinoma : An Eastern Cooperative Oncology Group Study. / Dreicer, Robert; Propert, Kathleen J.; Kuzel, Timothy; Kirkwood, John M.; O'Dwyer, Peter J.; Loehrer, Patrick.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 20, No. 3, 06.1997, p. 251-253.

Research output: Contribution to journalArticle

Dreicer, Robert ; Propert, Kathleen J. ; Kuzel, Timothy ; Kirkwood, John M. ; O'Dwyer, Peter J. ; Loehrer, Patrick. / A Phase II trial of edatrexate in patients with advanced renal cell carcinoma : An Eastern Cooperative Oncology Group Study. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1997 ; Vol. 20, No. 3. pp. 251-253.
@article{21aec89a94e649aebd5acd61096bfbde,
title = "A Phase II trial of edatrexate in patients with advanced renal cell carcinoma: An Eastern Cooperative Oncology Group Study",
abstract = "We performed a Phase II trial of edatrexate in 44 chemotherapy-naive patients with advanced renal cell carcinoma. Prior therapy with one biological-response modifier was permitted. Most patients had multiple sites of metastatic disease and were considered to have a poor prognosis using Eastern Cooperative Oncology Group criteria. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly with 5 weeks of therapy considered one cycle. Oral cryotherapy using ice chips was administered before each edatrexate dose. Thirty-seven patients were eligible and evaluable for toxicity and response. Two patients obtained a partial response, for an overall response rate of 5.4{\%} (95{\%} confidence interval of 0.6{\%}, 18.2{\%}); one patient remained in remission at 26+ months. Three treatment-related deaths occurred. Toxicity was severe, with stomatitis, myelosuppression, and other gastrointestinal side effects most prominent. Edatrexate in this dose and schedule has minimal activity in advanced renal cell carcinoma and is toxic.",
keywords = "Edatrexate, Renal cell carcinoma",
author = "Robert Dreicer and Propert, {Kathleen J.} and Timothy Kuzel and Kirkwood, {John M.} and O'Dwyer, {Peter J.} and Patrick Loehrer",
year = "1997",
month = "6",
doi = "10.1097/00000421-199706000-00008",
language = "English",
volume = "20",
pages = "251--253",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - A Phase II trial of edatrexate in patients with advanced renal cell carcinoma

T2 - An Eastern Cooperative Oncology Group Study

AU - Dreicer, Robert

AU - Propert, Kathleen J.

AU - Kuzel, Timothy

AU - Kirkwood, John M.

AU - O'Dwyer, Peter J.

AU - Loehrer, Patrick

PY - 1997/6

Y1 - 1997/6

N2 - We performed a Phase II trial of edatrexate in 44 chemotherapy-naive patients with advanced renal cell carcinoma. Prior therapy with one biological-response modifier was permitted. Most patients had multiple sites of metastatic disease and were considered to have a poor prognosis using Eastern Cooperative Oncology Group criteria. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly with 5 weeks of therapy considered one cycle. Oral cryotherapy using ice chips was administered before each edatrexate dose. Thirty-seven patients were eligible and evaluable for toxicity and response. Two patients obtained a partial response, for an overall response rate of 5.4% (95% confidence interval of 0.6%, 18.2%); one patient remained in remission at 26+ months. Three treatment-related deaths occurred. Toxicity was severe, with stomatitis, myelosuppression, and other gastrointestinal side effects most prominent. Edatrexate in this dose and schedule has minimal activity in advanced renal cell carcinoma and is toxic.

AB - We performed a Phase II trial of edatrexate in 44 chemotherapy-naive patients with advanced renal cell carcinoma. Prior therapy with one biological-response modifier was permitted. Most patients had multiple sites of metastatic disease and were considered to have a poor prognosis using Eastern Cooperative Oncology Group criteria. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly with 5 weeks of therapy considered one cycle. Oral cryotherapy using ice chips was administered before each edatrexate dose. Thirty-seven patients were eligible and evaluable for toxicity and response. Two patients obtained a partial response, for an overall response rate of 5.4% (95% confidence interval of 0.6%, 18.2%); one patient remained in remission at 26+ months. Three treatment-related deaths occurred. Toxicity was severe, with stomatitis, myelosuppression, and other gastrointestinal side effects most prominent. Edatrexate in this dose and schedule has minimal activity in advanced renal cell carcinoma and is toxic.

KW - Edatrexate

KW - Renal cell carcinoma

UR - http://www.scopus.com/inward/record.url?scp=0030917278&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030917278&partnerID=8YFLogxK

U2 - 10.1097/00000421-199706000-00008

DO - 10.1097/00000421-199706000-00008

M3 - Article

VL - 20

SP - 251

EP - 253

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 3

ER -