TY - JOUR
T1 - Phase IIstudy of ZD1694 in patients with advanced gastric cancer
AU - Meropol, Neal J.
AU - Pazdur, Richard
AU - Vincent, Mark
AU - Willson, James K V
AU - Kelsen, David P.
AU - Douglass, Harold O.
PY - 1996/11/26
Y1 - 1996/11/26
N2 - ZD1694 (Tomudex(TM)), a quinazoline folate analogue, is a potent and selective thymidylate synthase inhibitor. A phase II trial was undertaken to determine the efficacy and toxicity of ZD1694 in patients with advanced, measurable gastric adenocarcinoma, ZD1694, 3.0 mg/m2, was administered as a 15 min intravenous infusion every three weeks. Tumor measurements were obtained for response assessment every six weeks. Clinical examinations, adverse event assessments, and clinical laboratory tests were performed every three weeks. Thirty-three patients were enrolled. There were no objective responses to ZD1694. In general, treatment was well-tolerated. Grade 3 and 4 toxicities were infrequent, and included mucositis, nausea and vomiting, leukopenia, thrombocytopenia, and elevations of liver enzymes. Mild to moderate asthenia was common. Toxicities with ZD1694 were reversible and manageable. In conclusion, ZD 1694 has an acceptable toxicity profile but shows no antitumor activity in patients with advanced gastric cancer.
AB - ZD1694 (Tomudex(TM)), a quinazoline folate analogue, is a potent and selective thymidylate synthase inhibitor. A phase II trial was undertaken to determine the efficacy and toxicity of ZD1694 in patients with advanced, measurable gastric adenocarcinoma, ZD1694, 3.0 mg/m2, was administered as a 15 min intravenous infusion every three weeks. Tumor measurements were obtained for response assessment every six weeks. Clinical examinations, adverse event assessments, and clinical laboratory tests were performed every three weeks. Thirty-three patients were enrolled. There were no objective responses to ZD1694. In general, treatment was well-tolerated. Grade 3 and 4 toxicities were infrequent, and included mucositis, nausea and vomiting, leukopenia, thrombocytopenia, and elevations of liver enzymes. Mild to moderate asthenia was common. Toxicities with ZD1694 were reversible and manageable. In conclusion, ZD 1694 has an acceptable toxicity profile but shows no antitumor activity in patients with advanced gastric cancer.
KW - Chemotherapy
KW - Gastric cancer
KW - Thymidylate synthase
KW - Tomudex
KW - ZD1694
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U2 - 10.1097/00000421-199612000-00020
DO - 10.1097/00000421-199612000-00020
M3 - Article
C2 - 8931686
AN - SCOPUS:0029826136
SN - 0277-3732
VL - 19
SP - 628
EP - 630
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 6
ER -