A Phase II Trial of MGI-114 (NSC# 683863) Administered as a 5-Minute Infusion Daily for Five Days Every 4 Weeks in Patients With Previously Untreated Advanced Colorectal Cancer

Fecha de inicio: 1 de abril de 1999

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum Bidimensionally measurable disease Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and ascites are not considered measurable No CNS disease only CNS metastases with other sites of measurable disease allowed provided appropriate therapy for CNS metastases has been administered and patient is neurologically stable and does not require intravenous steroid or anticonvulsant therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (no platelet transfusion within 7 days) Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant uncontrolled medical or psychiatric illness No serious active infection No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless adequately treated and less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic use of growth factors except for documented febrile neutropenia or sepsis Chemotherapy: At least 12 months since prior fluorouracil based adjuvant or neoadjuvant chemotherapy No more than 1 prior regimen No prior chemotherapy for advanced metastatic colorectal cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the only site of measurable disease No concurrent radiotherapy Surgery: Not specified Other: See Disease Characteristics At least 30 days since prior investigational drug