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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT00030095
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor
* Metastatic or unresectable disease for which standard curative treatments do not exist or are no longer effective
* Clinically progressive disease documented by any of the following:
* New area of malignant disease
* Progression of soft-tissue metastases
* At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy
* Increases in prostate-specific antigen
* Lesions accessible for serial biopsy
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No prior allergic reactions to compounds of similar chemical or biological composition to 2-methoxyestradiol
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin)
* No concurrent chemotherapy for cancer
Endocrine therapy:
* Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients with prostate cancer except those with prior orchiectomy
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy for cancer
Surgery:
* See Endocrine therapy
Other:
* Recovered from prior therapy
* No other concurrent therapy for cancer
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030095
Study Brief:
Protocol Section:
NCT00030095