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 [ Designated as safety issue: No ]
  • Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death from colon cancer [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen [ Designated as safety issue: No ]
  • Radiological assessment of response to neoadjuvant treatment [ Designated as safety issue: No ]
  • Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D [ Designated as safety issue: No ]
  • Health service costs [ Designated as safety issue: No ]
  • Surgical morbidity/mortality [ Designated as safety issue: Yes ]
  • Chemotherapy toxicity [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Birmingham Clinical Trials Unit
Birmingham,, England, United Kingdom, B15 2RR
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
Birmingham Clinical Trials Unit
Investigators
Principal Investigator: Dion Morton, MD Birmingham Clinical Trials Unit
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00647530     History of Changes
Other Study ID Numbers: BCTU-FOXTROT-001, CDR0000590089, 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
Health Authority: Unspecified

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:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014