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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect 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. IFN alpha-2a will be given at 5 million U/m(2) SC days 1-6; LV, 200 mg/m(2), will be given as a short infusion over 30 minutes days 2-6, followed immediately by a 1 hour IV infusion of FUra days 2-6. The starting dose of FUra will be 425 mg/m(2)/d(1). Cycles will be repeated at three week intervals provided that the granulocyte count and platelet count have recovered to \&gte; 120...

Gender

ALL

Eligibility 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.