{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T19:29:44Z","timestamp":1761766184696},"reference-count":34,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2000,2,14]]},"abstract":"<jats:p> PURPOSE: This phase I trial sought to evaluate the toxicity of and determine the maximum-tolerated dose (MTD) for the two-drug regimen doxorubicin and gemcitabine (AG) followed by the three-drug regimen of ifosfamide, paclitaxel, and cisplatin (ITP) in patients with unresectable or metastatic transitional-cell carcinoma. <\/jats:p><jats:p> PATIENTS AND METHODS: Patients received AG every other week for six cycles followed by ITP every 3 weeks for four cycles. Five AG dose levels were investigated, up to doxorubicin 50 mg\/m<jats:sup>2<\/jats:sup> and gemcitabine 2,000 mg\/m<jats:sup>2<\/jats:sup>, to determine the MTD of the regimen. The dose and schedule of ITP were constant: ifosfamide 1,500 mg\/m<jats:sup>2<\/jats:sup> (days 1 to 3); paclitaxel 200 mg\/m<jats:sup>2<\/jats:sup> (day 1); and cisplatin 70 mg\/m<jats:sup>2<\/jats:sup> (day 1). Granulocyte colony-stimulating factor was given between all cycles of therapy. <\/jats:p><jats:p> RESULTS: Fifteen patients enrolled onto this phase I trial. AG was well tolerated at all dose levels, with no grade 3 or 4 myelosuppression. Toxicity experienced with ITP included grade 3 and 4 granulocytopenia in four patients and grade 3 nausea\/vomiting in three patients. No grade 3 and 4 neurotoxicity was observed. Eight of 14 assessable patients experienced a major response to AG, including five of six patients treated at the two highest AG dose levels. After completion of AG-ITP, nine of 14 assessable patients had a major response (three complete responses and six partial responses). <\/jats:p><jats:p> CONCLUSION: AG is a well-tolerated and active regimen. Sequential chemotherapy with AG-ITP is also well tolerated, and phase II investigation at the highest dose level is ongoing. <\/jats:p>","DOI":"10.1200\/jco.2000.18.4.840","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T07:02:08Z","timestamp":1487919728000},"page":"840-840","source":"Crossref","is-referenced-by-count":53,"title":["Phase I Evaluation of Sequential Doxorubicin Gemcitabine Then Ifosfamide Paclitaxel Cisplatin for Patients With Unresectable or Metastatic Transitional-Cell Carcinoma of the Urothelial Tract"],"prefix":"10.1200","volume":"18","author":[{"given":"Paul M.","family":"Dodd","sequence":"first","affiliation":[{"name":"From the Genitourinary Oncology ServiceDivision of Solid Tumor Oncology, Department of Medicine; Department of Radiology; the Division of Epidemiology and Biostatistics; and Division of Urology, Department of Surgery, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John A.","family":"McCaffrey","sequence":"additional","affiliation":[{"name":"From the Genitourinary Oncology ServiceDivision of Solid Tumor Oncology, Department of Medicine; Department of Radiology; the Division of Epidemiology and Biostatistics; and Division of Urology, Department of Surgery, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Hilton","sequence":"additional","affiliation":[{"name":"From the Genitourinary Oncology ServiceDivision of Solid Tumor Oncology, Department of Medicine; Department of Radiology; the Division of Epidemiology and Biostatistics; and Division of Urology, Department of Surgery, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Madhu","family":"Mazumdar","sequence":"additional","affiliation":[{"name":"From the Genitourinary Oncology ServiceDivision of Solid Tumor Oncology, Department of Medicine; Department of Radiology; the Division of Epidemiology and Biostatistics; and Division of Urology, Department of Surgery, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harry","family":"Herr","sequence":"additional","affiliation":[{"name":"From the Genitourinary Oncology ServiceDivision of Solid Tumor Oncology, Department of Medicine; Department of Radiology; the Division of Epidemiology and Biostatistics; and Division of Urology, Department of Surgery, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. 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