Interferon potentiates cytotoxic effects of 5-fluorouracil on cell proliferation of established human cell lines originating from neoplastic tissues.
T Miyoshi, S Ogawa, T Kanamori...
https://pubmed.ncbi.nlm.nih.gov/6187435Completed
Phase 2
All Genders
ID00001428
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
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Cytolytic activity of interferon-gamma and its synergism with 5-fluorouracil.
J Le, Y K Yip, J Vilcek
https://pubmed.ncbi.nlm.nih.gov/6436183Interferon effects upon the adenocarcinoma 38 and HL-60 cell lines: antiproliferative responses and synergistic interactions with halogenated pyrimidine antimetabolites.
L Elias, H A Crissman
https://pubmed.ncbi.nlm.nih.gov/2457431