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Gastric Adenocarcinoma With Peritoneal CarcinomatosisPhase 2CatuNeoNCT01504256

Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

A Phase 2 study testing catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel and Fluorouracil, leucovorin, oxaliplatin, docetaxel in people with Gastric Adenocarcinoma With Peritoneal Carcinomatosis and Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel and Fluorouracil, leucovorin, oxaliplatin, docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteGermany
Study dates
Oct 2011to Jul 2017
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

  • Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification)
  • Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
  • Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
  • Signed and dated informed consent before the start of specific protocol procedures
  • Age > 18 years
  • ECOG Performance Status of 0 or 1
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  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
  • Hemoglobin > 10.0 g/dl
  • Leukocyte count > 4.000/μl; absolute neutrophil count (ANC) > 2.000/μl
  • Platelet count > = 100.000/µl
  • Total bilirubin < 1,5 times the upper limit of normal
  • ALT and AST < 3 x upper limit of normal
  • Alkaline phosphatase < 5 x ULN
  • Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min
  • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations

Who cannot join

  • Distant metastasis other than peritoneal seedings
  • Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = < 1 year before enrolment
  • History of HIV infection or chronic hepatitis B or C
  • Active, clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
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  • Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
  • History of organ allograft
  • Patients undergoing renal dialysis
  • Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • Excluded therapies and medications, previous and concomitant:
  • Prior anti-cancer chemotherapy or immunotherapy.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery
  • Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Prof. Dr. F. Lordick

    Leipzig, 04103

Other trials in Germany

About this study

Official title: Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy

The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.

Being tested
catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel, Fluorouracil, leucovorin, oxaliplatin, docetaxel
Keywords
Adenocarcinoma, Esophagogastric Junction, Peritoneal Carcinomatosis, Catumaxomab, AIO-STO-0110
Medical subject headings
Adenocarcinoma, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxelDrug

    Also called Catumaxomab + FLOT

    Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10)

    and 7 days after the last catumaxomab infusion

    FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1)

  • Fluorouracil, leucovorin, oxaliplatin, docetaxelDrug

    Also called FLOT

    FLOT; 6 cycles q2w:

    Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)

Study groups in NCT01504256
Study groupRoleWhat they receive
catumaxomabExperimentalthis arm was stopped. the antibody previously used as a study drug is not available at this time. patients will be randomized only into the standard arm [Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10) and 7 days after the last catumaxomab infusion FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1))
Receives: Drug: catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel
standard therapyActive comparatorFLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)
Receives: Drug: Fluorouracil, leucovorin, oxaliplatin, docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of macroscopic complete remissions of peritoneal carcinomatosis

    Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy.

    Measured: Assessment after 14 - 18 weeks after start of treatment

Secondary outcomes (7)

  1. Surgical resection rate (R0, R1, R2)

    All tumor evaluation is performed according to RECIST

    Measured: Assessment after 14 - 18 weeks after start of treatment

  2. Overall survival (OS)

    The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored).

    Measured: Assessment over minimum 16 months up to 3 years

  3. Disease-free survival (DFS)

    Disease-free survival (DFS) will be defined as the time from surgery, resulting in a R0 finding and macroscopic complete remission of PC, to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). Patients with evidence of disease at surgery are counted as having the event at time = 0.

    Measured: Assessment over minimum 16 months up to 3 years

  4. Progression-free survival (PFS)

    Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation).

    Measured: Assessment over minimum 16 months up to 3 years

  5. Frequency, relationship, and severity of AEs

    Measured: Assessment over minimum 16 months up to 3 years

  6. Immunoreaction against tumor in tissue samples

    blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy)

    Measured: 14 - 18 weeks

  7. Detection of disseminated tumor cells via PCR

    blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)

    Measured: 14 - 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2017
  4. Study completionJul 2017

Resources

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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504256
Sponsor's protocol ID
AIO-STO-0110
Other IDs
2010-024111-13
Acronym
CatuNeo
Status last verified
Jan 2018
First submitted
3 Jan 2012
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel and Fluorouracil, leucovorin, oxaliplatin, docetaxel in people with Gastric Adenocarcinoma With Peritoneal Carcinomatosis and Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis, run by AIO-Studien-gGmbH 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 16 inclusion and 17 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 23 Jan 2018. 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?

Rate of macroscopic complete remissions of peritoneal carcinomatosis (time frame: Assessment after 14 - 18 weeks after start of treatment). 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 NCT01504256.

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 23 Jan 2018.

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