Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Carcinoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

preoperative and postoperative combination chemotherapy with bevacizumab

perioperative chemotherapy plus bevacizumab

complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.

cytoreductive surgery

Pump-driven intraperitoneal administration of oxaliplatin

Intraperitoneal Oxaliplatin

Wim P Ceelen, MD,PhD

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.

Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis

This will be estimated with the Dindo-Clavien classification

time interval between date of surgery and disease progression or death

calculated from date of surgery until death

percentage of patients receiving all planned courses

percentage of patients experiencing chemotherapy-related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) scoring system

will be scored with a 3 level regression scale

University Hospital, Ghent

Peritoneal Neoplasms

Abdominal Neoplasms

Peritoneal Diseases

Capecitabine

Antimetabolites

Intraperitoneal oxaliplatin 25 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Intraperitoneal oxaliplatin 50 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Intraperitoneal oxaliplatin 65 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Intraperitoneal oxaliplatin 85 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Intraperitoneal oxaliplatin 100 mg/m2 IP on day 1 of each cycle

Bevacizumab 5 mg/kg CIVI on day 1 of each cycle

Capecitabine PO BID on days 1-7 of each cycle.

Each cycle is 14 days long.

Benjamin Tan, M.D.

This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.

* To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
* To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
* To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen.

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

-Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis	NCT02399410	Colorectal Neop...	perioperative c... cytoreductive s... Intraperitoneal...	18 Years -	University Hospital, Ghent
Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer	NCT01061515	Carcinoma	Intraperitoneal... Bevacizumab Capecitabine	18 Years -	Washington University School of Medicine
Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer	NCT01061515	Carcinoma	Intraperitoneal... Bevacizumab Capecitabine	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for intraperitoneal oxaliplatin