Phase I feasibility study of intraperitoneal cisplatin and intravenous paclitaxel followed by intraperitoneal paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: Gynecologic Oncology Group study 9921.

Authors

Don Dizon

D. S. Dizon

Warren Alpert Medical School of Brown University, Providence, RI

D. S. Dizon , M. Sill , N. S. Gould , S. C. Rubin , S. D. Yamada , R. DeBernardo , R. S. Mannel , E. L. Eisenhauer , L. R. Duska , P. M. Fracasso

Organizations

Warren Alpert Medical School of Brown University, Providence, RI, Gynecologic Oncology Group Statistical and Data Center, Buffalo, NY, Women's Cancer Center of Nevada, Las Vegas, NV, University of Pennsylvania Medical Center, Philadelphia, PA, The University of Chicago, Chicago, IL, Case Comprehensive Cancer Center and Case Western Reserve University, Cleveland, OH, University of Oklahoma Health Sciences Center, Oklahoma City, OK, The Ohio State University College of Medicine, Columbus, OH, University of Virginia Health System, Charlottesville, VA, University of Virginia, Charlottesville, VA

Research Funding

NIH

Background: Intraperitoneal-containing 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. Methods: Patients with Stage IIB-IV epithelial ovarian, fallopian tube, primary peritoneal carcinomas or carcinosarcoma received paclitaxel 135 mg/m2 IV over 3 hours 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. Results: Twenty 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. Response was noted in one of nine (11%) patients with measurable disease, with stable disease in an additional four. Using GCIG criteria for CA-125 analysis, eighteen patients were evaluable and of these, 12 (67%) had a full response and 2 (11%) had a partial response for an overall response rate of 78%. Conclusions: This 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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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

NCT00814086

Citation

J Clin Oncol 29: 2011 (suppl; abstr 5066)

Abstract #

5066

Poster Bd #

17F

Abstract Disclosures

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