Phase I clinical trial of hepatic arterial infusion of cisplatin in combination with intravenous liposomal doxorubicin in patients with advanced cancer and dominant liver involvement |
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Authors: | Apostolia M Tsimberidou Stacy Moulder Siqing Fu Sijin Wen Aung Naing Agop Y Bedikian Shawn Daring Cynthia Uehara Chaan Ng Michael Wallace Luis Camacho Razelle Kurzrock |
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Institution: | 1. Phase I Program, Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA 2. Department of Biostatistics, M. D. Anderson Cancer Center, Houston, TX, USA 3. Department of Melanoma, M. D. Anderson Cancer Center, Houston, TX, USA 4. Department of Diagnostic Radiology, M. D. Anderson Cancer Center, Houston, TX, USA 5. Department of Interventional Radiology, M. D. Anderson Cancer Center, Houston, TX, USA 6. Oncology Consultants, P.A., Houston, TX, USA
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Abstract: | Purpose We conducted a phase I study of hepatic arterial infusion (HAI) cisplatin and systemic chemotherapy in patients with advanced cancer and dominant liver involvement. Methods Patients were treated with HAI cisplatin 100–125 mg/m2 (and 3,000 IU heparin) intraarterially and liposomal doxorubicin (doxil) 20–35 mg/m2 IV (day 1) every 28 days. A “3 + 3” study design was used. Results Thirty patients were treated (median age, 56 years). Diagnoses were breast cancer (n = 11), colorectal cancer (n = 8), ocular melanoma (n = 4), and other (n = 7). The median number of prior therapies was 5. The maximum tolerated dose (MTD) was at the 100/35 mg/m2 level. Dose-limiting toxicities were Grade 4 neutropenia (2 of 4 patients), and Grade 4 thrombocytopenia (n = 1) at the cisplatin 125 mg/m2 and systemic doxil 35 mg/m2 dose level. The most common toxicities were nausea/vomiting and fatigue. Of 24 patients evaluable for response, 4 (17%) had a partial response (PR) and 7 (29%) had stable disease (SD) for ≥4 months. Of the 11 patients with breast cancer, 3 (27%) had a PR and 5 (45%) had SD for ≥4 months. Of 4 patients with ocular melanoma, 1 had a PR and 1 SD for 4 months. One patient with hepatocellular carcinoma had SD for 4 months. Of 12 evaluable patients treated at the MTD, 2 (17%) had a PR and 5 (42%) had SD. Conclusion The MTD was HAI cisplatin 100 mg/m2 and systemic doxil 35 mg/m2. This regimen demonstrated antitumor activity, especially in breast cancer. |
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