A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers
Recurrent or Metastatic Colorectal Cancer
About this trial
This is an interventional diagnostic trial for Recurrent or Metastatic Colorectal Cancer focused on measuring Colorectal Cancer, Maximum tolerated dose
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
Sites / Locations
- Department of Oncology, National Taiwan University hospital
Arms of the Study
Arm 1
Experimental
A