PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES

NCT02086656 | Completed Phase 2

• 1 other identifier: COI-B
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases

Conditions

Colorectal Cancer Liver Metastases

Keywords

liver metastases; colorectal cancer; perioperative treatment

Outcome Measures

Primary Outcomes (1)

• Pathological response rate

  Primary: \- To evaluate the activity of the regimen with regards to major/complete pathological response. Major/complete pathological response is measured by pathologist in terms of tumor regression grade (TRG) as described by Rubbia-Brandt L, Annals of Oncology 2007 (percentage of vial residual cells 0-10%).

  Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment)

Secondary Outcomes (1)

• RECIST Response rate

  Available at week 9 after enrollment

Study Arms (1)

open label

EXPERIMENTAL

Single arm, open label

Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab

Interventions

capecitabine, oxaliplatin, irinotecan and bevacizumab DRUG

perioperative COI-B

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of colorectal adenocarcinoma.
• Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
• Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
• Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
• Age \>= 18 years
• Performance Status (ECOG \<2)
• Adequate organ function including the following:
• Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophil count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL .
• Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 xULN
• Renal : serum creatinin \<2.0xULN
• Patients compliance and geographic proximity that allows for adequate follow-up
• Patients must sign an informed consent document (ICD)
• Male and female patients with reproductive potential must use an approved contraceptive method.

You may not qualify if:

• Tumor involvement of liver \> 75%
• Chance of a liver remnant after surgery \< 25%
• Eligibility for concurrent radiotherapeutic treatment
• Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
• Previous treatment with more than 3 months of FOLFOX or FOLFIRI
• Previous therapy with bevacizumab or cetuximab or panitumumab
• Administration of other experimental drugs during the study.
• Body Mass Index \> 35
• Brain metastases.
• Pregnancy and breast-feeding.
• Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis.
• Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration.
• Previous dangerous life threatening toxicities from fluoropyrimidine.
• Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Mi, 20133, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Filippo de Braud, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: March 13, 2014
• Study Start: June 1, 2013
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

IT (1)