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:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00006257
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven advanced malignancy for which no satisfactory treatment exists
* Must have tumor accessible by biopsy
* Minimum of 1 baseline biopsy required
* No brain metastases or primary CNS tumor
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* SGOT and SGPT less than 2 times upper limit of normal unless due to presence of tumor
* Bilirubin normal
Renal:
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No uncompensated coronary artery disease by ECG or physical examination
* No myocardial infarction or severe unstable/angina within the past 6 months
* No severe peripheral vascular disease associated with diabetes mellitus
* No severe deep vein or arterial thrombosis within the past 3 months
Pulmonary:
* No pulmonary embolism within the past 3 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No unstable or severe concurrent medical condition
* No active uncontrolled infection
* No history of allergic reaction to paclitaxel or Cremophor
* No greater than grade 1 peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior SU5416
Chemotherapy:
* No prior paclitaxel
* Greater than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* Greater than 4 weeks since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
Other:
* Recovered from any prior investigational agents
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006257
Study Brief:
Protocol Section:
NCT00006257