Gastric CancerPhase 2NCT00352833
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
A Phase 2 study testing catumaxomab in people with Gastric Cancer and Gastric Adenocarcinoma, run by Neovii Biotech at 1 site in Germany.
Trial summary
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma
- What is being tested?
- catumaxomab
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Sep 2007
- Phase
- Phase 2
- 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
- Signed and dated informed consent
- Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
- Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
- Karnofsky index >= 70
- Negative pregnancy blood test at screening in women with childbearing potential
Who cannot join
- Presence of distant metastases
- Macroscopic and microscopic residual tumor present after surgery
- State after pancreas resection or thoracotomy
- Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
- Previous treatment with non-humanized mouse or rat monoclonal antibodies
- Known/suspected hypersensitivity to catumaxomab or similar antibodies
Show all 18Show fewer
- Any cancer disease or any cancer treatments within the last 5 years
- Presence of constant immunosuppressive therapy
- Inadequate renal function (creatinine > 1.5 x ULN)
- Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin >= 1.5 x ULN)
- Platelets < 75000 cells/mm³; absolute neutrophil count < 1500 cells/mm³
- Patient had a bowel obstruction within the last 30 days
- Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
- Presence of any acute or chronic systemic infection
- Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
- Patient is an employee of any involved study investigator or any involved institution including the study sponsor
- Parallel participation in another clinical trial or previous participation in this study
- Treatment with another investigational product during this study or during the last 30 days prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters.
Read the detailed description
A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to serosal infiltration after curative gastrectomy. Eligible patients will be centrally randomized by IVRS during operation to one of the two study groups in an 1:1 ratio: surgery plus catumaxomab or surgery alone.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg) which will be administered as an i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Being tested
- catumaxomab
- Keywords
- gastric cancer, investigational drug, adjuvant therapy, intraoperative, intraperitoneal, EpCAM-positive tumor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catumaxomabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcus Heiss, Prof. Dr., Principal investigator, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352833
- Sponsor's protocol ID
- IP-REM-GC-02
- Status last verified
- Jun 2007
- First submitted
- 14 Jul 2006
- Last updated
- 26 Oct 2007
- Results posted
- No
Publications
Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
PubMed 15906359Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
PubMed 11588051Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
PubMed 11410615Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
PubMed 10901380Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
PubMed 10415020
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone
- ClinicalTrials.gov ID
- NCT00352833
- Acronym / sponsor ID
- IP-REM-GC-02
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- gastric cancer, investigational drug, adjuvant therapy, intraoperative, intraperitoneal, EpCAM-positive tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Jul 2006 (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.
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters.
Detailed description
A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to serosal infiltration after curative gastrectomy. Eligible patients will be centrally randomized by IVRS during operation to one of the two study groups in an 1:1 ratio: surgery plus catumaxomab or surgery alone.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg) which will be administered as an i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent
- Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
- Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
- Karnofsky index >= 70
Key exclusion criteria (18 listed)
- Presence of distant metastases
- Macroscopic and microscopic residual tumor present after surgery
- State after pancreas resection or thoracotomy
- Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
- Previous treatment with non-humanized mouse or rat monoclonal antibodies
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 |
|---|---|---|
| catumaxomab | Drug | – |
Primary outcome
safety and efficacy data
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 26 Oct 2007.
- Background: PubMed 15906359Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
- Background: PubMed 11588051Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
- Background: PubMed 11410615Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
- Background: PubMed 10901380Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
- Background: PubMed 10415020Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
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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.
Marcus Heiss, Prof. Dr. principal investigator
Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing catumaxomab in people with Gastric Cancer and Gastric Adenocarcinoma, run by Neovii Biotech at 1 site in Germany.
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 6 inclusion and 18 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 26 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
safety and efficacy data. 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 NCT00352833, which also lists 5 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 26 Oct 2007.