Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070213
First received: October 3, 2003
Last updated: September 16, 2013
Last verified: June 2011
  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
Drug: FOLFOX regimen
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed

Resource links provided by NLM:


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
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: NCT00070213

Locations
United Kingdom
Clinical Trials and Research Unit of the University of Leeds
Leeds, England, United Kingdom, LS2 9JT
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00070213     History of Changes
Other Study ID Numbers: CDR0000330142, NCRI-FOCUS2, MRC-CR09, EU-20303
Study First Received: October 3, 2003
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 24, 2014