Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Procedure: cytoreductive surgery; Drug: perioperative chemotherapy plus bevacizumab; Drug: Intraperitoneal Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02399410

EC/2014/1042

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

bevacizumab and CRS with oxaliplatin

Experimental group

Description:

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Treatment:

Drug: perioperative chemotherapy plus bevacizumab

Procedure: cytoreductive surgery

Drug: Intraperitoneal Oxaliplatin