Clinical trial · Interventional
A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer
NCT00001428CI-TRIAL-00001323completedPhase 2ClinicalTrials.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)
This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced, measurable colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: Unresectable primary colorectal adenocarcinoma that is metastatic or recurrent. Objectively measurable disease required. No cerebral metastases. PRIOR/CONCURRENT THERAPY: Biologic Therapy: No history of intolerance to interferon alfa (IFN-A). At least 4 weeks since immunotherapy and recovered. Chemotherapy: No prior chemotherapy for metastatic or recurrent disease. At least 6 months since adjuvant chemotherapy with fluorouracil (5-FU) in combination with levamisole, leucovorin (CF), or IFN-A Interval waived for 5-FU (with or without CF) as a radiosensitizer only . No dose-limiting toxicity with prior 5-FU. Endocrine Therapy: Not specified Radiotherapy: At least 2 weeks since palliative radiotherapy and recovered. Prior definitive pelvic or whole or upper abdominal radiotherapy allowed in the absence of current radiation enteritis. Surgery: Prior surgery allowed with adequate healing/recovery Patient Characteristics: Age: 18 and over. Performance status: ECOG 0 or 1. Hematopoietic: AGC at least 2,000. Platelets at least 100,000. Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No MI within the past year. No active ischemic heart disease. No NYHA class III/IV status. No symptomatic arrhythmia. OTHER: No requirement for pharmacologic steroid doses for inflammatory or autoimmune disorders. Physiologic replacement doses of steroids allowed. No concurrent cimetidine or oxypurinol. No HIV antibody. No history of seizure disorder. No active infection or other serious concurrent medical illness that would preclude treatment. No second malignancy within 3 years except curatively treated: In situ carcinoma of cervix, Basal cell carcinoma of the skin. No pregnant or nursing women. Effective contraception required of fertile patients.
References
Publications (3)
- BACKGROUNDMiyoshi T, Ogawa S, Kanamori T, Nobuhara M, Namba M. Interferon potentiates cytotoxic effects of 5-fluorouracil on cell proliferation of established human cell lines originating from neoplastic tissues. Cancer Lett. 1983 Jan;17(3):239-47. doi: 10.1016/0304-3835(83)90160-x. PMID 6187435
- BACKGROUNDLe J, Yip YK, Vilcek J. Cytolytic activity of interferon-gamma and its synergism with 5-fluorouracil. Int J Cancer. 1984 Oct 15;34(4):495-500. doi: 10.1002/ijc.2910340411. PMID 6436183
- BACKGROUNDElias L, Crissman HA. Interferon effects upon the adenocarcinoma 38 and HL-60 cell lines: antiproliferative responses and synergistic interactions with halogenated pyrimidine antimetabolites. Cancer Res. 1988 Sep 1;48(17):4868-73. PMID 2457431