Clinical trial · Interventional
A Phase I Trial of HDFL48 in Recurrent or Metastatic Colorectal Cancers
A Phase I Trial of HDFL48(Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin) in Recurrent or Metastatic Colorectal Cancers
NCT00155558CI-TRIAL-00000805completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Colorectal Cancer | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil, Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: 5-Fluorouracil, Leucovorin
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose and dose limiting toxicity
- timeFrame
- 2000~2005
Secondary outcomes (1)
- measure
- response
- timeFrame
- 2000~2005
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.