| General information |
| Database: | DB00921 |
| Objective: | Patients with malignant ascites due to epithelial cancer received four 3h intraperitoneal catumaxomab infusions with/without intravenous prednisolone (25 mg) premedication before each infusion. |
| Authors: | Sehouli J, et al |
| Title: | Catumaxomab with and without prednisolone premedication for the treatment of malignant ascites due to epithelial cancer: results of the randomisedphase IIIb CASIMAS study. |
| Journal: | Med Oncol. |
| Year: | 2014 |
| PMID: | 24965536 |
| Trial Design |
| Clinical Trial Id: | NCT00822809 |
| Agent: | catumaxomab
|
| Target: | epithelial celladhesion molecule (EpCAM), CD3, type I, IIa and III Fc¦Ã receptors
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | epithelial cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | catumaxoma with predniso |
| Study Type: | results of the randomisedphase IIIb CASIMAS study. |
| Key Patients Feature: | pts with malignant ascites due to epithelial cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | catumaxoma with predniso versus catumaxoma |
| Treatment Info: | Patients with malignant ascites due to epithelial cancer received four 3h intraperitoneal catumaxomab infusions with/without intravenous prednisolone (25 mg) premedication before each infusion. |
| Primary End Point: | a composite safety score calculated from the incidence and intensity of the most frequent catumaxomabrelated adverse events (pyrexia, nausea, vomiting and abdominal pain). Puncturefree survival (PuFS) was a coprimary endpoint. |
| Secondary End Point: | Time to next puncture (TTPu) and overall survival (OS) |
| Patients Number: | 219 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PuFS (30 vs. 37 days) and TTPu (78 vs. 102 days) were shorter in the catumaxomab plus prednisolone arm than in the catumaxomab arm, but the differences were not statistically significant (p = 0.402 and 0.599, respectively) |
| Median OS A vs. C: | Median OS was longer in the catumaxomab plus prednisolone arm than in the catumaxomab arm (124 vs. 86 days), but the difference was not statistically significant (p = 0.186). |
| Adverse Event(agent arm): | The primary safety endpoint was a composite safety score calculated from the incidence and intensity of the most frequent catumaxomabrelated adverse events (pyrexia, nausea, vomiting and abdominal pain). |
| Conclusions: | The superiority of catumaxomab plus prednisolone versus catumaxomab alone could not be proven for the primary endpoint. Prednisolone did not result in a significant reduction in the main catumaxomabrelated adverse events. The study confirms the safety and efficacy of catumaxomab administered as four 3h intraperitoneal infusions for the treatment of malignant ascites. |