A phase II study of cetuximab/paclitaxel/carboplatin for the initial treatment of advanced stage ovarian, primary peritoneal, and fallopian tube cancer

Abstract

5047 Background: Elevated expression of EGFR in ovarian cancer is associated with poor prognosis. This study is being conducted to assess the feasibility of adding the anti-EGFR antibody cetuximab (C225) to standard upfront chemotherapy for ovarian cancer. Methods: Previously untreated patients (pts) with stage III or IV epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma are eligible for this study. KPS must be ≥70% and tumors must be EGFR positive. Pts receive an initial dose of C225 of 400 mg/m2 on Day 1 of Cycle 1, followed by 250 mg/m2 weekly. Paclitaxel (P, 175 mg/m2) and carboplatin (C, AUC=6mg/ml.min) are given on D1 of each 3-wk cycle. Pts may receive a max. of 6 cycles during initial treatment. Pts with complete clinical response (cCR) receive 6 months consolidation with weekly C225. The primary objective is progression-free survival (PFS); response rate and toxicity are also assessed. A total of 39 eligible pts are planned for accrual; 31 pts have been accrued to date. Results: The first 17 pts completing 6 cycles of initial treatment are reported. Median age 54 yrs. (range 37–75). 10 pts (IIIA-1, IIIB-1, IIIC-8) were opt debulked, 4 pts (IIIC-4) subopt debulked and 3 pts were Stage IV. 71% ovarian, 23% primary peritoneal, 6% fallopian tube carcinoma. Histology: 100% serous adenocarcinoma. 15 of 17 pts were evaluable for response; 2 pts with wrong diagnosis were unevaluable. 13 pts (87%) had unconfirmed cCR. 10 (100%) of opt debulked pts and 3 (75%) of subopt debulked pts had cCR. 15 pts (88%) received the planned dose of C225; 16 pts (94%) and 17 pts (100%) received planned doses of P and C, respectively. Median no. (range): C225 doses, 18 (1–18); C225 doses/cycle, 3 (1–3); and cycles of C225/P/C completed, 6 (1–6). Gr 3 toxicities: febrile neutropenia (12%), diarrhea (6%), and hypersensitivity (6%). No Gr 4 toxicities were noted. Fifteen pts (88%) had acneform rash (Gr 1/2 53%/35%). Conclusions: Preliminary data for this ongoing study indicate the combination of C225 with P and C is well tolerated in this patient population. Data on tolerability of prolonged maintenance cetuximab will be available for presentation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Bristol-Myers Squibb