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Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00647530
First received: March 28, 2008
Last updated: August 6, 2013
Last verified: November 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without panitumumab in treating patients with colon cancer.

PURPOSE: This randomized phase III trial is studying giving fluorouracil together with oxaliplatin and panitumumab to see how well it works compared with giving fluorouracil and oxaliplatin without panitumumab in treating patients with high-risk colon cancer that can be removed by surgery.


Condition Intervention Phase
Colorectal Cancer Biological: panitumumab Drug: capecitabine Drug: fluorouracil Drug: oxaliplatin Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: proteomic profiling Genetic: western blotting Other: immunohistochemistry staining method Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: FOxTROT - Fluoropyrimidine, Oxaliplatin and Targeted Receptor Pre-Operative Therapy: a Controlled Trial in High-Risk Operable Colon Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence or persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomization
  • Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab

Secondary Outcome Measures:
  • Death from colon cancer
  • Overall survival
  • Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen
  • Radiological assessment of response to neoadjuvant treatment
  • Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D
  • Health service costs
  • Surgical morbidity/mortality
  • Chemotherapy toxicity
  • Adverse events

Estimated Enrollment: 1050
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon

    • Radiological T-staging of T4 or poor prognosis T3 (extramural depth > 5 mm)
    • Resectable disease
  • Tumor not within 15 cm of the anal verge, as judged by sigmoidoscopy, or below the level of the sacral promontory, as judged by sagittal CT or MRI scan
  • No concurrent obstruction and not previous defunctioning or stenting

    • Patients presenting with acute colonic obstruction may enter the trial only after successful defunctioning or stenting, and when recovered to a fitness level consistent with the other eligibility criteria
  • No peritonitis secondary to perforated tumor
  • No evidence of distant metastases or peritoneal or omental nodules (M1)

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Hemoglobin > 10.0 g/dL
  • WBC > 3,000/mm^3
  • Platelets > 1000,000/mm^3
  • Bilirubin < 25 μmol/L
  • Glomerular filtration rate > 50 mL/min
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months (females) 3 months (males) after completion of study therapy
  • Able and willing to provide written informed consent for the study
  • No serious medical comorbidity, including any of the following:

    • Uncontrolled inflammatory bowel disease
    • Uncontrolled angina or recent myocardial infarction (within the past 6 months)
    • Other serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
  • No other malignant disease within the past 5 years except for nonmelanoma skin cancer
  • No history of interstitial pneumonitis or pulmonary fibrosis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No indication for radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647530

Locations
United Kingdom
Birmingham Clinical Trials Unit
Birmingham,, England, United Kingdom, B15 2RR
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Queen Elizabeth Hospital
Gateshead, England, United Kingdom, NE9 6SX
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Royal Lancaster Infirmary
Lancaster, England, United Kingdom, LA1 4RP
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Southport and Formby District General Hospital
Southport, England, United Kingdom, PR8 6PN
Sandwell General Hospital
West Bromwich, England, United Kingdom, B71 4HJ
Sponsors and Collaborators
University of Birmingham
Investigators
Principal Investigator: Dion Morton, MD University of Birmingham
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00647530     History of Changes
Other Study ID Numbers: BCTU-FOXTROT-001
CDR0000590089 ( Registry Identifier: PDQ (Physician Data Query) )
ISCRTN 87163246
EUDRACT 2007-001987-55
EU-20830
MREC-07/S0703/57
UKCRN 3771
Study First Received: March 28, 2008
Last Updated: August 6, 2013

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017