Abstract | OBJECTIVE: METHODS: The study is a single-arm open-label multicenter US phase II study. Patients received 4 three-hour intraperitoneal catumaxomab infusions (10, 20, 50, and 150 μg within 10 days). The primary end point was the percentage of patients with at least a 4-fold increase in the puncture-free interval (PuFI) relative to the pretreatment interval. The main secondary end points were puncture-free survival, overall survival, ascites symptoms, and safety. Time to first therapeutic puncture (TTPu) was analyzed post hoc. RESULTS: Forty patients were screened, and 32 patients (80%) were treated. Seven patients (23%) achieved the primary end point. The median PuFI was prolonged 2-fold from 12 to 27.5 days. The median TTPu was prolonged 4-fold from 12 to 52 days. The median puncture-free survival and overall survival were 29.5 and 111 days, respectively. Nineteen patients (59%) required puncture after catumaxomab treatment. Ascites symptoms improved in most of the 13 predefined categories. At study end, most symptoms were still improved compared with screening. The most frequent treatment-related adverse events were related to cytokine release ( vomiting, nausea, pyrexia, fatigue, and chills) or intraperitoneal administration ( abdominal pain). Transient increases in liver parameters and transient decreases in blood lymphocytes were regularly observed but were generally without clinical relevance. CONCLUSIONS:
Catumaxomab prolonged PuFI and TTPu had a beneficial effect on quality of life, as shown by the improvement in ascites symptoms, and had an acceptable safety profile, which is consistent with its mode of action.
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Authors | Jonathan S Berek, Robert P Edwards, Lynn P Parker, Leslie R DeMars, Thomas J Herzog, Samuel S Lentz, Robert T Morris, Wallace L Akerley, Robert W Holloway, Michael W Method, Steven C Plaxe, Joan L Walker, Hilke Friccius-Quecke, Carolyn N Krasner |
Journal | International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
(Int J Gynecol Cancer)
Vol. 24
Issue 9
Pg. 1583-9
(Nov 2014)
ISSN: 1525-1438 [Electronic] England |
PMID | 25254563
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Bispecific
- catumaxomab
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Topics |
- Adult
- Aged
- Antibodies, Bispecific
(administration & dosage)
- Ascites
(prevention & control)
- Drug Resistance, Neoplasm
(drug effects)
- Fallopian Tube Neoplasms
(drug therapy, mortality, pathology)
- Female
- Follow-Up Studies
- Humans
- Infusions, Parenteral
- Middle Aged
- Neoplasm Staging
- Ovarian Neoplasms
(drug therapy, mortality, pathology)
- Peritoneal Neoplasms
(drug therapy, mortality, secondary)
- Prognosis
- Quality of Life
- Survival Rate
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