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A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers

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: NCT00155558
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 25, 2007
Information provided by:
National Taiwan University Hospital

Brief Summary:
To determine the maximum tolerated dose and dose limiting toxicity of 5-FU and leucovorin with novel 48-hour infusion schedule, and to collect toxicity profile at different dose level of 5-FU/LV 48-hour infusion.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic Colorectal Cancer Drug: 5-Fluorouracil, Leucovorin Phase 1

Detailed Description:

Colorectal cancer is one of the major in Taiwan.It caused 3128 deaths in 1999, and represented the No.3 cancer killer in both male and female population of Taiwan.

Recently, evidence has accumulated that weekly, 24-hour infusion of high-dose 5-FU may improve the response rate and survival time compared with 5-FU bolus regiment. In a randomized multicenter trial of metastatic colorectal cancer, Kohne et al reported an overall response rate of 44%and a median survival time of 16 months using a weekly-times-six schedule of infusional 5-FU (2600mg/m2 24-hours infusion). In another randomized study for advanced colorectal cancer, de Gramont et al reported a significantly better outcome in patients treated by a similar schedule which combined "bolus plus infusional" 5-FU compared to "bolus" 5-FU. These results suggest that 24-or 48-hour infusion of high-dose 5-FU is more effective than the conventional bolus schedules.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Trial of HDFL48(Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin) in Recurrent or Metastatic Colorectal Cancers
Study Start Date : March 2001
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: 5-Fluorouracil, Leucovorin

Primary Outcome Measures :
  1. To determine the maximum tolerated dose and dose limiting toxicity [ Time Frame: 2000~2005 ]

Secondary Outcome Measures :
  1. response [ Time Frame: 2000~2005 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Pathologically confirmed recurrent or metastatic colorectal adenocarcinoma
  • Patients are indicated for 5-FU (1st-line after recurrence/metastasis), OR have failed 5-FU ,treatment with other schedules
  • At least one bi-dimensionally measurable lesion(s)
  • Previous C/T, R/T >= 4 weeks
  • KPS > 50%
  • Age >= 18 years
  • Fasting TG > 70 mg/dL (within 7 days)
  • WBC >= 3,000/uL or ANC >= 1,500/uL
  • Plt >= 75,000/uL
  • Cre<= 1.5 mg/dL
  • Proteinuria < 1+
  • Normal T-bil
  • AST/ ALT <= 3.5-fold of ULN

Exclusion Criteria:

  • Concomitant anticancer therapy or radiotherapy
  • CNS metastasis
  • Pregnant women
  • Patients who have second malignancy
  • Symptomatic heart disease (significant arrhythmia, CHF or MI within 3 months of entry)
  • Active infection exists
  • Extensive liver disease or liver cirrhosis
  • Patients who refuse Port-A catheter implantation

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): NCT00155558

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Department of Oncology, National Taiwan University hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Kun-Huei Yeh, M.D., Ph.D. Department of Oncology, National Taiwan University hospital

Layout table for additonal information Identifier: NCT00155558    
Other Study ID Numbers: 159I13
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: November 2000
Keywords provided by National Taiwan University Hospital:
Colorectal Cancer, Maximum tolerated dose
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs