Clinical trial NCT00087282 (phase 2, status: completed)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: alvocidib, irinotecan hydrochloride
SMILES: CN1CC[C@@H]([C@H](O)C1)C1=C(O)C=C(O)C2=C1OC(=CC2=O)C1=CC=CC=C1Cl, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Eligibility criteria:

        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