Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction (NCT00113113) | Clinical Trial Compass
CompletedPhase 1
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
United States54 participantsStarted 2001-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* The patient has any serious, uncontrolled intercurrent illness or infection.
* The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
* The patient is pregnant or nursing.