A Phase I Investigation of Carboxyamido-triazole (CAI) Modulated by Ketoconozole In Patients With Advanced Malignancies

Date de début de l'étude : 1 mai 1998

DISEASE CHARACTERISTICS: Histologically or cytologically proven refractory or recurrent nonhematologic malignancies Measurable or evaluable disease by radiographic or clinical examination PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 70-100% Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Albumin at least 3 g/dL Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min No concurrent neurotoxicities greater than grade 1 from previous chemotherapy No concurrent neuropathy greater than grade 1 Not pregnant Effective contraceptive method must be used by fertile patients during and up to 2 months after study No serious uncontrolled medical illness No history of active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes PRIOR CONCURRENT THERAPY: No concurrent isoniazid No concurrent rifampin At least 4 weeks since chemotherapy At least 6 weeks since nitrosoureas therapy At least 3 months since suramin therapy No prior carboxyamidotriazole No concurrent steroids (except dose required for adrenal insufficiency) No concurrent tamoxifen No prior radiotherapy within 4 weeks of study No prior total gastrectomy or total ileocolectomy No concurrent therapy with H2 antagonists, barbiturates, calcium channel blockers, terfenadine, astemizole, cisapride, digitoxin, quinidine, amiodarone, carbamazepine, imipramine, or antacids No concurrent erythromycin