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Recurrent or Metastatic Colorectal CancerPhase 1NCT00155558

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

A Phase 1 study testing 5-Fluorouracil, Leucovorin in people with Recurrent or Metastatic Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
5-Fluorouracil, Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteTaiwan
Study dates
Mar 2001to Dec 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Oncology, National Taiwan University hospital

    Taipei, 100

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
5-Fluorouracil, Leucovorin
Keywords
Colorectal Cancer, Maximum tolerated dose
Medical subject headings
Recurrence, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-Fluorouracil, LeucovorinDrug

Study groups in NCT00155558
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: 5-Fluorouracil, Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose and dose limiting toxicity

    Measured: 2000~2005

Secondary outcomes (1)

  1. response

    Measured: 2000~2005

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMar 2001
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00155558
Sponsor's protocol ID
159I13
Status last verified
Nov 2000
First submitted
9 Sep 2005
Last updated
25 Jul 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5-Fluorouracil, Leucovorin in people with Recurrent or Metastatic Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose and dose limiting toxicity (time frame: 2000~2005). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00155558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007.

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