A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer

Date de début de l'étude : 1 décembre 1999

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic cancer that is considered incurable and for which no standard curative therapy exists No primary CNS malignancies Measurable evidence of residual, recurrent, or metastatic disease No prior CNS metastases with residual abnormal findings on neuroradiologic studies Prior CNS metastases allowed provided at least 6 months from definitive therapy and a normal CT or MRI of the brain PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 mg/dL (may be post transfusion) Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring parenteral antibiotics No documented abnormal CNS exam with seizure disorder or major neuropsychiatric problems PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior hematopoietic growth factor or cytokine therapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for steroid replacement therapy or chronic low dose (no greater than 10 mg/day oral prednisone) therapy for nonmalignant conditions No concurrent hormonal therapy except oral contraceptives or hormonal replacement therapy Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other: At least 4 weeks since other prior investigational drugs No concurrent oral or parenteral anticoagulants except anticoagulants for central venous catheters including low dose warfarin (1-2 mg/day) and/or heparin No concurrent oral COX-2 specific inhibitors (e.g., celecoxib or rofecoxib)