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

NCT ID: NCT00155558

Last Updated: 2007-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2005-12-31

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.

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.

Conditions

Recurrent or Metastatic Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

5-Fluorouracil, Leucovorin

Intervention Type: DRUG

Interventions

5-Fluorouracil, Leucovorin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Kun-Huei Yeh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University hospital

Locations

Department of Oncology, National Taiwan University hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

159I13

Identifier Type: -

Identifier Source: org_study_id