Status:
COMPLETED
A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Recurrent or Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-ho...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00155558
Start Date
March 1 2001
End Date
December 1 2005
Last Update
July 25 2007
Active Locations (1)
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1
Department of Oncology, National Taiwan University hospital
Taipei, Taiwan, 100