Efficacy of intraperitoneal immunotherapy with the trifunctional antibody catumaxomab in addition to systemic chemotherapy in patients with peritoneal carcinomatosis from colorectal or gastric cancer

Phase 2

Completed

• Conditions: Peritoneal carcinomatosis from colorectal and gastric cancer (adenocarcinoma); Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN53770195
• Lead Sponsor: niversity of Witten/Herdecke (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-28
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female patient aged 18 years or older
2. Signed and dated informed consent
3. Patient has peritoneal carcinomatosis of colorectal or gastric adeno-carcinoma (histologically confirmed)
4. Eastern Cooperative Oncology Group (ECOG) status 1 or 2 (Karnofsky index >= 70)

Exclusion Criteria

1. Symptomatic ascites (estimated accululation of more than 1500 ml by sonography and computer tomography and puncture of more than 1500 ml)
2. Ileus or abdominal obstruction with the need of surgical intervention at inclusion or parenteral feeding (> 30% of daily calorie intake)
3. Previous use of non-humanised monoclonal mouse or rat antibodies
4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies
5. Presence of any acute or chronic systemic infection
6. Pre-existing heart failure > New York Heart Association (NYHA) class II
7. Pregnancy or breast feeding
8. Other concurrent uncontrolled medical conditions
9. Previous Catumaxomab therapy
10. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
11. Inadequate renal function (Creatinine > 1,5 x ULN)
12. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 2 x ULN)
13. Inadequate bone marrow function with platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3 or a proportion of < 15% of lymphocytes in differential blood count
14. Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
15. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study
16. Parallel participation in another clinical trial or previously in this study
17. Treatment with another investigational product during this study or during the last 30 days prior to study start (day 0)
18. Under no circumstances must a patient be enrolled in this study more than once

Study & Design

• Study Type: Interventional
• Study Design: Not specified