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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00004920
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant pleural mesothelioma
* No CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ZUBROD, ECOG, WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10.0 g/dL
* WBC at least 4,000/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.46 mg/dL
* Albumin at least 3.0 g/dL
* ALAT/ASAT less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver involvement)
Renal:
* Creatinine less than 1.69 mg/dL
* Creatinine clearance at least 65 mL/min
Cardiovascular:
* Not specified
Pulmonary:
* Not specified
Other:
* No other prior or concurrent malignancies within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
* No prior malignant melanoma, hypernephroma or breast carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* No uncontrolled infections
* No psychological, familial, sociological, or geographical condition that precludes study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy before first disease progression
Chemotherapy:
* No prior systemic or intracavitary cytotoxic chemotherapy
* No other prior or concurrent chemotherapy before first disease progression
* No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)
Endocrine therapy:
* No concurrent hormonal therapy except corticosteroids before first disease progression
Radiotherapy:
* At least 4 weeks since prior radiotherapy to target lesion and progression observed
* Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field
Surgery:
* Prior surgery allowed if followed by disease progression
Other:
* At least 1 month since prior investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004920
Study Brief:
Protocol Section:
NCT00004920