Clinical trial · Interventional
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion
NCT00114205CI-TRIAL-00003273completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| therapeutic thoracoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose by adverse event evaluation 1 month after treatment
Secondary outcomes (2)
- measure
- Pharmacokinetics by serum and pleural fluid analyses through 1 month
- measure
- Clinical response by chest x-ray response and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.