Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study

Civil Hospices of Lyon

Status and phase: Withdrawn; Phase 2

Conditions: Colorectal Carcinomatosis

Treatments: Drug: bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).; Procedure: Cytoreductive surgery combined with HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT03161041

69HCL17_0239

Details and patient eligibility

About

Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.

Sex: All

Ages: 18 to 85 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 m2
• 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)

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0 participants in 1 patient group

Bevacizumab and CRS with oxaliplatin

Experimental group

Description:

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Treatment:

Procedure: Cytoreductive surgery combined with HIPEC

Drug: bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).