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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 (FOxTROT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647530
First Posted: March 31, 2008
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Birmingham
  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 assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high risk operable colon cancer.


Condition Intervention Phase
Colorectal Cancer Biological: panitumumab Drug: capecitabine Drug: fluorouracil Drug: oxaliplatin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pre- plus Post-operative chemotherapy (+/- Panitumumab) vs standard post-operative chemotherapy.
Masking: None (Open Label)
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 University of Birmingham:

Primary Outcome Measures:
  • Freedom from recurrence or persistent disease (including failure of macroscopic disease clearance at primary surgery) within the first two years following randomization [ Time Frame: 2 year post randomization ]
  • Pathological down-staging as measured by depth of extramural spread among patients allocated to preoperative chemotherapy with or without panitumumab [ Time Frame: Time of surgery ]

Secondary Outcome Measures:
  • Death from colon cancer [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
  • Freedom from recurrence or persistent disease at 2 years (panitumumab comparison) [ Time Frame: 2 years ]
  • Pathological assessment of downstaging (involvement of lymph nodes, serosa, and resection margin) and quality of resection specimen [ Time Frame: at surgery ]
  • Quality of resection specimen and distance to high-tie [ Time Frame: post surgery ]
  • Radiological assessment of response to neoadjuvant treatment [ Time Frame: prior to surgery ]
  • Quality of life by EORTC QLQ C-30 and EuroQol EQ-5D [ Time Frame: before surgery, before 1st post-op chemo, 1 year post randomization ]
  • Lenght of hospital stay [ Time Frame: post surgery ]
  • Surgical morbidity/mortality [ Time Frame: 30 days post surgery ]
  • Chemotherapy toxicity [ Time Frame: during chemotherapy administration ]
  • Adverse events [ Time Frame: throughout the trial, up to 2 years ]

Enrollment: 1053
Actual Study Start Date: May 15, 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre&Post Op Chemo
12 weeks of OxFP neuoadjuvantly followed by surgery and 18 weeks of OxFP
Drug: capecitabine Drug: fluorouracil Drug: oxaliplatin
Experimental: Pre&Post Op Chemo with P-mab
12 weeks of OxFP and panitumumab neuoadjuvantly followed by surgery and 18 weeks of OxFP alone.
Biological: panitumumab Drug: fluorouracil Drug: oxaliplatin
Active Comparator: Post Op Chemo
surgery followed by 24 weeks of OxFP.
Drug: capecitabine Drug: fluorouracil Drug: oxaliplatin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer.
  • A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:

    • Either radiological high risk (rT4 or rT3 tumour with extramural extension ≥ 5mm)
    • Or radiological intermediate risk (rT3 tumour with <5mm extramural extension) and younger age/good general health
  • Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
  • Adequate full blood count: WBC >3.0 x109/l; Plts >100 x109/l. Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.
  • Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
  • Adequate hepatobiliary function: bilirubin < 25 μmol/l (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study.)
  • Aged 18 or over
  • WHO performance status of 0, 1 or 2
  • If female and of childbearing potential, must:

    • Have a negative pregnancy test ≤72hours prior to initiating study treatment
    • Agree to avoid pregnancy during and for 6 months after study treatment
  • If male with a partner of childbearing potential, must:

    - Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment

  • Patient able and willing to provide written informed consent for the study

EXCLUSION CRITERIA

  • Any patient for whom radiotherapy is advised by the MDT
  • Strong evidence of distant metastases or peritoneal nodules (M1)
  • Peritonitis (secondary to perforated tumour)
  • Colonic obstruction that has not been defunctioned
  • Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
  • Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
  • Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5%

ADDITIONAL EXCLUSION CRITERIA FOR PANITUMUMAB RANDOMISATION

  • RAS-mutant or unknown RAS status tumours
  • Allocated post-operative chemotherapy
  • History of interstitial pneumonitis or pulmonary fibrosis
  • History of severe or life-threatening hypersensitivity reactions
  • Serum magnesium levels within the normal range at trial entry (which can include intravenous correction)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of Birmingham
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
First Submitted: March 28, 2008
First Posted: March 31, 2008
Last Update Posted: August 2, 2017
Last Verified: July 2017

Keywords provided by University of Birmingham:
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
Capecitabine
Fluorouracil
Oxaliplatin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs