RT Journal Article SR Electronic T1 Randomized Phase II Trial of Paclitaxel Plus Carboplatin Therapy Versus Irinotecan Plus Cisplatin Therapy as First-Line Chemotherapy for Clear Cell Adenocarcinoma of the Ovary: A JGOG Study JF International Journal of Gynecologic Cancer JO Int J Gynecol Cancer FD BMJ Publishing Group Ltd SP 240-247 OP 240-247 DO 10.1111/IGC.0b013e3181cafb47 VO 20 IS 2 A1 Satoshi Takakura A1 Masashi Takano A1 Fumiaki Takahashi A1 Toshiaki Saito A1 Daisuke Aoki A1 Noriyuki Inaba A1 Kiichiro Noda A1 Toru Sugiyama A1 Kazunori Ochiai A1 on behalf of the Japanese Gynecologic Oncology Group (JGOG) YR 2010 UL http://ijgc.bmj.com/content/20/2/240-247.abstract AB Introduction: Paclitaxel plus carboplatin (TC) is generally considered to be the "gold standard" regimen for treatment of epithelial ovarian carcinomas. Little data are available, however, on the use of this regimen in patients with clear cell adenocarcinoma of the ovary (CCC). Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC. We compared these 2 combinations in patients with CCC.Methods: Patients (n = 99) with CCC were randomly assigned to receive either 180 mg/m2 paclitaxel on day 1 plus AUC 6 mg/mL × minute carboplatin on day 1 every 21 days (TC arm) or 60 mg/m2 irinotecan hydrochloride on days 1, 8, 15 plus 60 mg/m2 cisplatin on day 1 every 28 days (CPT-P arm).Results: Percentages of patients receiving the scheduled 6 cycles of chemotherapy in the TC and CPT-P arms were 70.8% and 72.0%, respectively. Although toxicity was well tolerated in both arms, the toxicity profile of each arm differed. Progression-free survival (PFS) showed no significant difference between the 2 treatment groups. Because there were more patients with large residual disease in the CPT-P arm, we performed a subset analysis by removing those patients, and then compared the PFS with that of patients without residual disease or with residual disease less than 2 cm. The PFS tended to be longer in the CPT-P group, although the difference was not statistically significant.Conclusions: A phase III randomized trial is required to elucidate the effectiveness of CPT-P combination chemotherapy for CCC.