NCT00155558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

July 25, 2007

Status Verified

November 1, 2000

First QC Date

September 9, 2005

Last Update Submit

July 23, 2007

Conditions

Recurrent or Metastatic Colorectal Cancer

Keywords

Colorectal Cancer, Maximum tolerated dose

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose and dose limiting toxicity

    2000~2005

Secondary Outcomes (1)

  • response

    2000~2005

Study Arms (1)

A

EXPERIMENTAL
Drug: 5-Fluorouracil, Leucovorin

Interventions

5-Fluorouracil, LeucovorinDRUG
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, National Taiwan University hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

RecurrenceColorectal Neoplasms

Interventions

FluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Kun-Huei Yeh, M.D., Ph.D.

    Department of Oncology, National Taiwan University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

March 1, 2001

Study Completion

December 1, 2005

Last Updated

July 25, 2007

Record last verified: 2000-11

Locations

TW(1)