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Clinical Trial
Journal Article
Intravenous/intraperitoneal paclitaxel and intraperitoneal carboplatin in patients with epithelial ovarian, fallopian tube, or peritoneal carcinoma: a feasibility study.
International Journal of Gynecological Cancer 2012 January
OBJECTIVE: This study aimed to evaluate intravenous (IV)/intraperitoneal (IP) paclitaxel and IP carboplatin (TCipTip therapy) feasibility in epithelial ovarian (EOC), fallopian tube (FTC), or peritoneal carcinoma (PC) patients.
METHODS: From December 2007 to August 2010, 20 women with histologically confirmed stage IC to IV EOC, FTC, or PC received 6 TCipTip cycles after the primary cytoreductive surgery. Intravenous paclitaxel was administered at 135 mg/m followed by IP carboplatin based on the area under the curve = 6 on day 1; IP paclitaxel at 60 mg/m was administered on day 8. The toxicity grade was determined by CTCAE version 3.0. The institutional review board requested we reduce the IP paclitaxel dose in the first cycle to ensure safety.
RESULTS: Twenty women, including 18 with EOC, 1 with stage IIC FTC, and 1 with stage IV primary PC, received TCipTip therapy. There were 12 serous, 5 endometrioid, 1 mucinous, 1 clear cell adenocarcinoma, and 1 mixed carcinoma (clear cell and endometrioid) cases. Eleven women achieved optimal status at primary surgery. Grade 3/4 hematologic toxicity incidence was 73% (neutrocytopenia), 9% (thrombocytopenia), and 24% (anemia). Grade 3/4 nonhematologic toxicities were observed in 5 patients (4 with grade 3 allergy and 1 with grade 3 ileus). Twelve patients (60%) completed more than 6 chemotherapy cycles. Reasons for interruption included paclitaxel allergy, grade 2 abdominal pain, carboplatin allergy during the seventh cycle, disease progression, pleural embolism, ileus, and address change.
CONCLUSIONS: Toxicities for TCipTip therapy were acceptable; this therapy is feasible for EOC, FTC, or PC patients. Further TCipTip therapy evaluation is warranted.
METHODS: From December 2007 to August 2010, 20 women with histologically confirmed stage IC to IV EOC, FTC, or PC received 6 TCipTip cycles after the primary cytoreductive surgery. Intravenous paclitaxel was administered at 135 mg/m followed by IP carboplatin based on the area under the curve = 6 on day 1; IP paclitaxel at 60 mg/m was administered on day 8. The toxicity grade was determined by CTCAE version 3.0. The institutional review board requested we reduce the IP paclitaxel dose in the first cycle to ensure safety.
RESULTS: Twenty women, including 18 with EOC, 1 with stage IIC FTC, and 1 with stage IV primary PC, received TCipTip therapy. There were 12 serous, 5 endometrioid, 1 mucinous, 1 clear cell adenocarcinoma, and 1 mixed carcinoma (clear cell and endometrioid) cases. Eleven women achieved optimal status at primary surgery. Grade 3/4 hematologic toxicity incidence was 73% (neutrocytopenia), 9% (thrombocytopenia), and 24% (anemia). Grade 3/4 nonhematologic toxicities were observed in 5 patients (4 with grade 3 allergy and 1 with grade 3 ileus). Twelve patients (60%) completed more than 6 chemotherapy cycles. Reasons for interruption included paclitaxel allergy, grade 2 abdominal pain, carboplatin allergy during the seventh cycle, disease progression, pleural embolism, ileus, and address change.
CONCLUSIONS: Toxicities for TCipTip therapy were acceptable; this therapy is feasible for EOC, FTC, or PC patients. Further TCipTip therapy evaluation is warranted.
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