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Trial record 42 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Tailored Treatment in Metastatic Colorectal Cancer

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. Identifier: NCT00396487
Recruitment Status : Terminated (Only one patient included as per Feb. 4, 2008.)
First Posted : November 7, 2006
Last Update Posted : June 11, 2015
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat Phase 3

Detailed Description:

The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU.

Capecitabine is metabolised to 5-FU through a number of enzymatic steps. It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (TP) in many human tumors compared to normal tissue. TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation. Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU. A number of small investigations have indicated that patients with 2R/2R TS polymorphism have a higher response rate than heterozygous patients.

The TS and MTHFR polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples.

At present single agent chemotherapy is based on three drugs (5-FU, capecitabine, and Irinotecan) with almost the same overall activity. It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
Study Start Date : November 2006
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The primary end point is
  2. Response according to RECIST criteria.

Secondary Outcome Measures :
  1. Secondary end points are
  2. Progression free survival
  3. Overall survival
  4. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic colorectal cancer
  • Histopathological verification of the primary tumor
  • Measurable disease according to RESIST criteria
  • Single agent chemotherapy indicated
  • Performance status >=2
  • Age >= 60 years
  • Life expectancy > 3 months
  • Adequate liver and kidney function as evaluated by bilirubin <= 3 times of normal upper limit, ALAT <= 3 times upper normal limit (<= 5 times upper normal limit in case of liver metastases), serum creatinine <= 1.5 times normal upper limit.
  • ANC >=1.5 x 109/l and platelets >= 100 x 109/l
  • Informed consent

Exclusion Criteria:

  • Patients with CNS metastases
  • Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri
  • Previous chemotherapy for metastatic disease
  • Adjuvant chemotherapy < 6 months before inclusion
  • Patients with previous major toxic or allergic reaction to the protocol drugs

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 identifier (NCT number): NCT00396487

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Aalborg Hospital
Aalborg, Denmark, 9100
Aarhus University Hospital
Aarhus, Denmark, 8000
Copenhagen, Denmark, 2100
Sydvestjysk Hospital Esbjerg
Esbjerg, Denmark, 6700
Herlev Hospital
Herlev, Denmark, 2730
Herning Central Hospital
Herning, Denmark, 7400
Næstved Hospital
Næstved, Denmark, 4700
Odense University Hospital
Odense, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark, 4000
Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Vejle Hospital
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Principal Investigator: Anders Jakobsen, Prof, MDSc Department of Oncology, Vejle Hospital, 7100 Vejle, DK-Denmark

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Responsible Party: Vejle Hospital Identifier: NCT00396487     History of Changes
Other Study ID Numbers: TT-2006-002957-56
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by Vejle Hospital:
Metastatic colorectal cancer
tailored treatment
genetic markers
gene polymorphism
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs