Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
| Estimated 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 |
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| United Kingdom | |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting |
| Birmingham, England, United Kingdom, B15 2TH | |
| Contact: Contact Person 44-121-472-1311 | |
| Birmingham Clinical Trials Unit | Recruiting |
| Birmingham,, England, United Kingdom, B15 2RR | |
| Contact: Contact Person 44-121-627-2283 Dion.morton@uhb.nhs.uk | |
| Queen Elizabeth Hospital | Recruiting |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Contact: Contact Person 44-191-482-0000 | |
| Huddersfield Royal Infirmary | Recruiting |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Contact: Contact Person 44-1484-342-000 | |
| Royal Lancaster Infirmary | Recruiting |
| Lancaster, England, United Kingdom, LA1 4RP | |
| Contact: Contact Person 44-1524-659-44 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-206-6400 | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Contact Person 44-151-334-1155 | |
| Derriford Hospital | Recruiting |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Contact: Contact Person 44-175-277-7111 | |
| Southport and Formby District General Hospital | Recruiting |
| Southport, England, United Kingdom, PR8 6PN | |
| Contact: Contact Person 44-1704-547-471 | |
| Sandwell General Hospital | Recruiting |
| West Bromwich, England, United Kingdom, B71 4HJ | |
| Contact: Contact Person 44-21-553-1831 ext. 3817 | |
| 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: | CDR0000590089, BCTU-FOXTROT-001, ISCRTN 87163246, EUDRACT 2007-001987-55, EU-20830, MREC-07/S0703/57, UKCRN 3771 |
| Study First Received: | March 28, 2008 |
| Last Updated: | February 13, 2009 |
| 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 Colonic Diseases Digestive System Diseases Gastrointestinal 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 May 22, 2013