Phase I safety study of farletuzumab, carboplatin, and pegylated liposomal doxorubicin (PLD) in subjects with platinum-sensitive epithelial ovarian cancer (EOC).

Authors

null

D. Jelovac

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD

D. Jelovac , D. K. Armstrong , S. Weil , M. Phillips , B. M. Schwartz , J. M. Estes , R. D. Alvarez

Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, Morphotek, Exton, PA, Schwartz Gyn Onc PA, Brightwaters, NY, University of Alabama at Birmingham, Birmingham, AL

Research Funding

Other

Background: Farletuzumab (FAR) is a humanized monoclonal antibody that binds to the folate receptor alpha, a potentially attractive target since it is over-expressed in EOC but is largely absent in normal epithelium. A Phase I dose escalation of FAR in platinum-resistant EOC showed no dose-limiting toxicities. A Phase II study of FAR with carboplatin and paclitaxel in platinum-sensitive EOC in first relapse showed a 93% patient benefit and 20% of second remissions were longer than first remission. In a recent Phase III study in relapsed platinum-sensitive EOC, the PLD/carboplatin combination showed superiority in progression free survival compared to carboplatin/paclitaxel. The current study is being conducted to assess the safety of FAR in combination with PLD/carboplatin in women with platinum-sensitive EOC in first or second relapse. Methods: A multicenter, single-arm study enrolled 15 subjects aged 47 to 82 with platinum-sensitive EOC in first or second relapse defined by either CA-125 or Response Evaluation Criteria In Solid Tumors (RECIST) criteria between July 2010 and January 2011 for treatment with weekly FAR 2.5mg/kg in combination with carboplatin AUC 4-5 and PLD 30mg/m2 every 4 weeks for 6 cycles. Following 6 cycles of combination, maintenance treatment with weekly single agent FAR 2.5mg/kg continues until disease progression. The study’s primary objective is to assess the safety of FAR/carboplatin/PLD by standard assessment and grading using NCI CTCAEv3. Results: Preliminary safety data showed that patients tolerated treatment well. In one patient FAR administration was interrupted due to gastrointestinal toxicity. Two patients required delay in carboplatin/PLD administration due to neutropenia. Palmar-plantar erythrodysesthesia was observed in two subjects. No cardiac toxicity was appreciated with FAR/carboplatin/PLD treatment. No severe adverse events have been documented and all subject remain on study to date. Conclusions: These preliminary safety data indicate that combination of FAR, carboplatin and PLD is well tolerated. Complete safety profile will be assessed and final results will be presented.

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Abstract Details

Meeting

2011 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT00738699

Citation

J Clin Oncol 29: 2011 (suppl; abstr 5056)

Abstract #

5056

Poster Bd #

16D

Abstract Disclosures