Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Adenocarcinoma With Peritoneal Carcinomatosis, Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis, Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis

Thank you

Trial Information

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


Inclusion Criteria:



- 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

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of macroscopic complete remissions of peritoneal carcinomatosis

Outcome Description:

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

Outcome Time Frame:

Assessment after 14 - 18 weeks after start of treatment

Safety Issue:

No

Principal Investigator

Florian Lordick, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medizinische Klinik III; Städtisches Klinikum Braunschweig gGmbH

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

AIO-STO-0110

NCT ID:

NCT01504256

Start Date:

October 2011

Completion Date:

December 2014

Related Keywords:

  • Gastric Adenocarcinoma With Peritoneal Carcinomatosis
  • Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis
  • Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis
  • Adenocarcinoma
  • Esophagogastric Junction
  • Peritoneal Carcinomatosis
  • Catumaxomab
  • AIO-STO-0110
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Stomach Neoplasms

Name

Location