Overview
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
Status:
Completed
Completed
Trial end date:
2000-12-01
2000-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Fluorouracil
Interferon-alpha
Interferons
Leucovorin
Levoleucovorin
Criteria
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.