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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Fluorouracil; Leucovorin

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