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Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2007

Sponsors and Collaborators: University of Leeds
Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070213
  Purpose

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Quality of Life
 Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: quality-of-life assessment
 Phase III

Genetics Home Reference related topics:   Colorectal Cancer  

MedlinePlus related topics:   Cancer   Colorectal Cancer  

ChemIDplus related topics:   Leucovorin Calcium   Citrovorum factor   Folinic acid calcium salt pentahydrate   Leucovorin   Capecitabine   Fluorouracil   Oxaliplatin   Calcium gluconate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed

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

Primary Outcome Measures:
  • Compare progression-free survival (PFS) in pts. treated w/ leucovorin calcium + fluorouracil (MdG) vs leucovorin calcium + fluorouracil + oxaliplatin (OxMdG) and in pts. treated w/ capecitabine (Cap) vs capecitabine + oxaliplatin (OxCap) at 1 yr [ Designated as safety issue: No ]
  • Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 14 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare health assessment, including quality of life, in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap at baseline and 14 and 24 weeks [ Designated as safety issue: No ]
  • Compare toxicity/adverse events in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: Yes ]
  • Compare overall failure-free survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
  • Compare overall survival in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
  • Compare health economics in patients treated with MdG vs OxMdG and in patients treated with Cap vs OxCap [ Designated as safety issue: No ]
  • Compare health assessment in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
  • Compare toxicity/adverse events in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap at baseline and 24 weeks [ Designated as safety issue: Yes ]
  • Compare patients acceptability in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
  • Compare PFS in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]
  • Compare health economics in patients treated with MdG vs Cap and in patients treated with OxMdG vs OxCap [ Designated as safety issue: No ]

Estimated Enrollment:   460
Study Start Date:   September 2003

 Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:

    • Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease
    • Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor
  • Unidimensionally measurable disease

  • Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances:

    • Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol
    • Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal

  • Creatinine clearance greater than 50 mL/min OR
  • Glomerular filtration rate greater than 30 mL/min

Cardiovascular

  • No uncontrolled angina
  • No recent myocardial infarction

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No partial or complete bowel obstruction
  • No concurrent severe uncontrolled medical illness that would preclude study treatment
  • No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication
  • No other prior or concurrent malignant disease that would preclude study treatment or assessment of response
  • No prior neuropathy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium
  • More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium
  • No prior systemic palliative chemotherapy for metastatic disease

Endocrine therapy

  • Not specified

Radiotherapy

  • See Chemotherapy

Surgery

  • Not specified

Other

  • No concurrent brivudine or sorivudine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070213

Locations
United Kingdom, England
Clinical Trials and Research Unit of the University of Leeds     Recruiting
      Leeds, England, United Kingdom, LS2 9JT
      Contact: Phil Quirke     44-113-233-3412        
Cookridge Hospital     Recruiting
      Leeds, England, United Kingdom, LS16 6QB
      Contact: Matthew T. Seymour, MA, MD, FRCP     44-113-267-3411        
Medical Research Council Clinical Trials Unit     Recruiting
      London, England, United Kingdom, NW1 2DA
      Contact: Gareth Griffiths     44-20-7670-4704        
United Kingdom, Wales
Velindre Cancer Center at Velindre Hospital     Recruiting
      Cardiff, Wales, United Kingdom, CF14 2TL
      Contact: Alison Brewster, MD     44-29-2031-6220        

Sponsors and Collaborators
University of Leeds
Medical Research Council

Investigators
Investigator:     Matthew T. Seymour, MA, MD, FRCP     Cookridge Hospital    
Investigator:     Gareth Griffiths     Medical Research Council    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Seymour MT, Maughan TS, Wasan HS, et al.: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: the FOCUS2 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9030, 500s, 2007.

Study ID Numbers:   CDR0000330142, NCRI-FOCUS2, MRC-CR09, EU-20303
First Received:   October 3, 2003
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00070213
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
quality of life  
adenocarcinoma of the colon  
adenocarcinoma of the rectum  
stage IV rectal cancer  
stage IV colon cancer
recurrent rectal cancer
recurrent colon cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Quality of Life
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Oxaliplatin
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on July 03, 2008

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