A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma

Date de début de l'étude : 1 juin 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma * Advanced disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Prior local therapy (e.g., surgery, hepatic arterial embolization, radiofrequency ablation, or cryoablation) allowed provided therapy was completed ≥ 8 weeks before study entry AND ≥ 1 of the following conditions are met: * Target lesion was not subjected to local therapy * 25% increase in the size of target lesion within the field of prior local therapy * Lesions treated with external beam radiotherapy are not acceptable as target lesions * Child-Pugh class A or B status if liver cirrhosis is present * Score 7 or 8 only * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * See Disease Characteristics * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No deep vein thrombosis within the past 6 months * Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible * No myocardial infarction within the past 6 months * No cardiac arrhythmia within the past 6 months * Rate-controlled atrial fibrillation allowed if stable for at least 6 months Pulmonary * No pulmonary embolus within the past 6 months * Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No prior allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol or irinotecan * No clinically significant gastrointestinal bleeding requiring hospitalization within the past month * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or superficial bladder tumors \[Ta, Tis, or T1\] PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic biologic therapy Chemotherapy * No prior systemic chemotherapy for hepatocellular carcinoma * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * No prior organ allograft Other * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent vitamins, antioxidants, or herbal preparations and supplements * Single-tablet multivitamin allowed * No other concurrent investigational agents * No other concurrent anticancer agents or therapies