CancerPhase 3CASIMASNCT00822809
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers
A Phase 3 study testing Catumaxomab and Prednisolone in people with Cancer and Neoplasms, run by Neovii Biotech at 4 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Catumaxomab and Prednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2008to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Neoplasms, Carcinoma, Malignant Ascites
- Being tested
- Catumaxomab, Prednisolone
- Keywords
- Cancer, Neoplasms, Carcinoma, Malignant Ascites, Drug therapy, Antineoplastic Protocols, Immunotherapy, Phase III, trifunctional antibody, monoclonal antibody, EpCAM
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatumaxomabDrug
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
PrednisoloneDrug
25 mg premedication
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 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. Receives: Drug: Catumaxomab; Drug: Prednisolone |
| B | Other | Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication. Receives: Drug: Catumaxomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
Measured: 6 months
Puncture-free survival defined as the time from clock start to first need for therapeutic ascites puncture or death, whichever occurs first.
Measured: 6 months
Secondary outcomes (3)
Safety measured by • Incidence of all AEs, • Changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis), • Physical examination, • Vital signs.
Measured: 6 months
Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment
Measured: 6 months
immune monitoring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Lordick, PD Dr. med., Principal investigator, Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822809
- Sponsor's protocol ID
- IP-CAT-AC-03
- Acronym
- CASIMAS
- Status last verified
- Aug 2012
- First submitted
- 23 Dec 2008
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lordick F, Ott K, Weitz J, Jager D. The evolving role of catumaxomab in gastric cancer. Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. doi: 10.1517/14712598.8.9.1407.
PubMed 18694358Burges A, Wimberger P, Kumper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jager M, Strohlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905. doi: 10.1158/1078-0432.CCR-06-2769.
PubMed 17606723Shen J, Zhu Z. Catumaxomab, a rat/murine hybrid trifunctional bispecific monoclonal antibody for the treatment of cancer. Curr Opin Mol Ther. 2008 Jun;10(3):273-84.
PubMed 18535935Fossati M, Buzzonetti A, Monego G, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological changes in the ascites of cancer patients after intraperitoneal administration of the bispecific antibody catumaxomab (anti-EpCAMxanti-CD3). Gynecol Oncol. 2015 Aug;138(2):343-51. doi: 10.1016/j.ygyno.2015.06.003. Epub 2015 Jun 3.
PubMed 26049121
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00822809
- Acronym / sponsor ID
- CASIMAS / IP-CAT-AC-03
- Conditions
- Cancer, Neoplasms, Carcinoma, Malignant Ascites
- Keywords
- Cancer, Neoplasms, Carcinoma, Malignant Ascites, Drug therapy, Antineoplastic Protocols, Immunotherapy, Phase III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Catumaxomab, Drug: PrednisolonePatients 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. |
| B | Other | Drug: CatumaxomabCatumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CatumaxomabCatumaxomab 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 | Drug | A, B |
| Prednisolone25 mg premedication | Drug | A |
Primary outcome
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
Time frame: 6 months
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
3 secondary outcomes
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
Time to next ascites puncture, number of ascites punctures until end of lifetime, overall survival, anti-cancer treatment
Time frame: 6 months
immune monitoring
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Background: PubMed 18694358Lordick F, Ott K, Weitz J, Jager D. The evolving role of catumaxomab in gastric cancer. Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. doi: 10.1517/14712598.8.9.1407.
- Background: PubMed 17606723Burges A, Wimberger P, Kumper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jager M, Strohlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905. doi: 10.1158/1078-0432.CCR-06-2769.
- Background: PubMed 18535935Shen J, Zhu Z. Catumaxomab, a rat/murine hybrid trifunctional bispecific monoclonal antibody for the treatment of cancer. Curr Opin Mol Ther. 2008 Jun;10(3):273-84.
- Derived from this study: PubMed 26049121Fossati M, Buzzonetti A, Monego G, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological changes in the ascites of cancer patients after intraperitoneal administration of the bispecific antibody catumaxomab (anti-EpCAMxanti-CD3). Gynecol Oncol. 2015 Aug;138(2):343-51. doi: 10.1016/j.ygyno.2015.06.003. Epub 2015 Jun 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Lordick, PD Dr. med. principal investigator
Med. Klinik III, Städtisches Klinikum Braunschweig gGmbH, Celler STr. 38, 38114 Braunschweig
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Catumaxomab and Prednisolone in people with Cancer and Neoplasms, run by Neovii Biotech at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822809, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.