Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Bevacizumab; Oxaliplatin

Criteria

Inclusion Criteria:

• biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.

• absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.

• resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.

• complete macroscopic cytoreduction at the time of surgery (CC-0/1)

• good general health status (Karnofsky index > 70%)

• expected life expectancy more than 6 months

• no other malignancy than disease under study

• serum creatinine < 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m

• serum total bilirubin < 1.5 mg/dl

• platelet count > 100,000/ml

• hemoglobin > 9g/dl

• neutrophil granulocytes > 1,500/ml

• International Normalized Ration (INR) 2 or < 2

• Absence of alcohol and/or drug abuse

• No inclusion in other clinical trials interfering with the study protocol

• No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol

• Absence of heart failure (NYHA 2 or > 2) or significant coronary artery disease

• No pregnancy or breast feeding

• Adequate contraception in fertile patients

Exclusion Criteria:

• No written informed consent

• tumour in the presence of obstruction

• evidence of extra-abdominal disease or extensive liver metastasis

• peritoneal cancer index > 25

• active bacterial, viral or fungal infection

• active gastro-duodenal ulcer

• parenchymal liver disease (any stage cirrhosis)

• uncontrolled diabetes mellitus

• severe obstructive or restrictive respiratory insufficiency

• psychiatric pathology capable of affecting comprehension and judgment faculty

• Known allergy to oxaliplatin