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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00005794
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable
* Refractory to further treatment with known forms of effective therapy
* No clinically active CNS metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* SGOT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 6 months after study participation
* Maintaining a reasonable state of nutrition consistent with weight maintenance
* No recent history of weight loss greater than 10% of current body weight
* No frequent vomiting/poor alimentation
* No other serious concurrent medical illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy
* Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 21 days since prior major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00005794
Study Brief:
Protocol Section:
NCT00005794