Tumors
Conditions
Keywords
rubitecan, Orathecin, 9-nitrocamptothecin, solid tumors, organ dysfunction, renal dysfunction, hepatic dysfunction, RFS 2000
Brief 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.
Interventions
DRUGRubitecan
Sponsors
Astex Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed