Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT00045318
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists
* Renal function as defined by the following parameters:
* Normal (creatinine clearance (CrCl) greater than 80 mL/min)
* Mild dysfunction (CrCl 50-80 mL/min)
* Moderate dysfunction (CrCl 30-50 mL/min)
* Severe dysfunction (CrCl less than 30 mL/min)
* End-stage renal disease (requiring dialysis)
* No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9.0 g/dL
Hepatic
* Bilirubin normal
* AST or ALT no greater than 2 times upper limit of normal
* Albumin at least 2.8 g/dL
Renal
* See Disease Characteristics
Cardiovascular
* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction within the past 6 months
Other
* No concurrent serious infection
* No other life-threatening illness
* No overt psychosis or mental disability or other incompetency that would preclude informed consent
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent anticancer biologic therapy
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered
* No prior exatecan mesylate
* No other concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent anticancer hormonal therapy
* Concurrent megestrol for appetite stimulation allowed
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent anticancer radiotherapy
Surgery
* At least 4 weeks since prior major surgery and recovered
* No concurrent anticancer surgery
Other
* At least 4 weeks since prior investigational drugs including analgesics or antiemetics
* At least 1 week since prior grapefruit juice
* No other concurrent anticancer therapy
* No other investigational drugs during and for 4 weeks after study
* No concurrent grapefruit juice
* No other concurrent anticancer cytotoxic therapy
* Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00045318
Study Brief:
Protocol Section:
NCT00045318