Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
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Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patient is at least 18 years of age.
The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
The patient has measurable disease.
The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
The patient's estimated life expectancy is at least 8 weeks.
The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
The patient has adequate bone marrow function.
The patient must not have active central nervous system (CNS) metastases.
The patient has any serious, uncontrolled intercurrent illness or infection.
The patient is receiving anti-retroviral therapy (HAART) for HIV infection.