CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers
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Purpose
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.
A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Neoplasms Carcinoma Malignant Ascites |
Drug: Catumaxomab Drug: Prednisolone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer |
- Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Puncture-free survival defined as the time from clock start to first need for therapeutic ascites puncture or death, whichever occurs first. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety measured by • Incidence of all AEs, • Changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis), • Physical examination, • Vital signs. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- immune monitoring [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 230 |
| Study Start Date: | December 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab. Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter. |
Drug: Catumaxomab
Catumaxomab will be infused 4 times within 11 days as follows: 10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10 25 mg premedication
|
|
B
Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.
|
Drug: Catumaxomab
Catumaxomab will be infused 4 times within 11 days as follows: 10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10 |
Detailed Description:
Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Patients with malignant ascites requiring therapeutic ascites puncture
- Histological confirmed diagnosis of epithelial cancer
- Patients where standard therapy is not available or no longer feasible
- Karnofsky index ≥60 %
- Life expectancy >12 weeks
Key Exclusion Criteria:
- Concomitant treatment with other investigational product, chemo-, or radiotherapy
- Recent exposure to an investigational product
- Known or suspected hypersensitivity to catumaxomab or similar antibodies
- Inadequate respiratory, renal or hepatic function
- Inadequate blood count (platelets, neutrophils)
- Required entirely parenteral nutrition
- Patients with ileus or subileus within the last 30 days
- Liver metastases with volume >70 % of liver tissue
- Known portal vein obstruction
- Known Brain metastases
- Acute or chronic infection
- Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status
- Albumin lower than 3 g/dL or total protein < 6g/dL
Contacts and Locations| France | |
| Study Site | |
| Several, France | |
| Germany | |
| Study site | |
| Several, Germany | |
| Italy | |
| Study Site | |
| Several, Italy | |
| Spain | |
| Study Site | |
| Several, Spain | |
| Principal Investigator: | Florian Lordick, PD Dr. med. | Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig |
More Information
Publications:
| Responsible Party: | Fresenius Biotech GmbH |
| ClinicalTrials.gov Identifier: | NCT00822809 History of Changes |
| Other Study ID Numbers: | IP-CAT-AC-03 |
| Study First Received: | December 23, 2008 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Fresenius Biotech GmbH:
|
Cancer Neoplasms Carcinoma Malignant Ascites Drug therapy Antineoplastic Protocols |
Immunotherapy Phase III trifunctional antibody monoclonal antibody EpCAM |
Additional relevant MeSH terms:
|
Ascites Neoplasms Carcinoma Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Antibodies, Bispecific Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013