Phase I feasibility study of intraperitoneal cisplatin and intravenous paclitaxel followed by intraperitoneal paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: a gynecologic oncology group study |
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Authors: | Dizon Don S Sill Michael W Gould Natalie Rubin Stephen C Yamada S Diane Debernardo Robert L Mannel Robert S Eisenhauer Eric L Duska Linda R Fracasso Paula M |
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Institution: | aProgram in Women's Oncology, Women & Infants' Hospital/The Warren Alpert Medical School of Brown University, Providence, RI 02905, USA;bGynecologic Oncology Group Statistical and Data Center, Buffalo, NY 14263, USA;cDivision of Gynecologic Oncology, Carilion Clinic, Roanoke, VA 24016, USA;dGynecologic Oncology, University of Pennsylvania Cancer Center, Philadelphia, PA 19104, USA;eGynecologic Oncology, University of Chicago, Chicago, IL 60637, USA;fGYN/ONC, University Hospitals Case Medical Center, Cleveland, OH 44106, USA;gGynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA;hGYN Oncology, Ohio State University, Columbus Cancer Council, Columbus, OH 43026, USA;iWomen's Oncology Program, UVA Cancer Center, and Department of Obstetrics–Gynecology, University of Virginia, Charlottesville, VA 22908, USA |
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Abstract: | PurposeIntraperitoneal chemotherapy has shown a survival advantage over intravenous chemotherapy for women with newly diagnosed optimally debulked epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. However, significant toxicity has limited its acceptance. In an effort to reduce toxicity, the Gynecologic Oncology Group conducted a Phase I study to evaluate the feasibility of day 1 intravenous (IV) paclitaxel and intraperitoneal (IP) cisplatin followed by day 8 IP paclitaxel on an every 21-day cycle.MethodsPatients with Stage IIB-IV epithelial ovarian, fallopian tube, primary peritoneal carcinomas or carcinosarcoma received paclitaxel 135 mg/m2 IV over 3 h followed by cisplatin 75 mg/m2 IP on day 1 and paclitaxel 60 mg/m2 IP on day 8 of a 21 day cycle with 6 cycles planned. Dose-limiting toxicity (DLT) was defined as febrile neutropenia or dose-delay of greater than 2 weeks due to failure to recover counts, or Grade 3–5 non-hematologic toxicity occurring within the first 4 cycles of treatment.ResultsTwenty of 23 patients enrolled were evaluable and nineteen (95%) completed all six cycles of therapy. Three patients experienced a DLT consisting of infection with normal absolute neutrophil count, grade 3 hyperglycemia, and grade 4 abdominal pain.ConclusionsThis modified IP regimen which administers both IV paclitaxel and IP cisplatin on day one, followed by IP paclitaxel on day eight, of a twenty-one day cycle appears feasible and is an attractive alternative to the intraperitoneal treatment regimen administered in GOG-0172. |
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Keywords: | Ovarian cancer Intraperitoneal chemotherapy Cisplatin Paclitaxel Phase I trial |
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