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 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT00114205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed malignant pleural effusion (MPE)
* Symptomatic disease
* Candidate for thoracoscopic surgery for treatment of MPE
* No known or suspected ipsilateral pleurodesis that would preclude surgery
* No bilateral MPEs
* No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR
* Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)
* Bilirubin normal
* INR ≤ 1.5
Renal
* Creatinine ≤ 1.8 mg/dL
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No concurrent systemic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00114205
Study Brief:
Protocol Section:
NCT00114205