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 J.
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
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U2 - 10.1097/00000421-199706000-00008
DO - 10.1097/00000421-199706000-00008
M3 - Article
C2 - 9167747
AN - SCOPUS:0030917278
SN - 0277-3732
VL - 20
SP - 251
EP - 253
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -
