Clinical trial · Interventional
Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating paclitaxel to several degrees above body temperature and infusing it to the affected area around the tumor may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| isolated perfusion | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable
* Bilateral metastases allowed
* Unresectable bronchoalveolar carcinomas allowed
* Previously treated primary lung cancer allowed
* Disease outside confines of thorax allowed, provided bulk of disease in the chest is clearly the greatest threat to survival and/or extrathoracic disease is controlled
* No potentially treatable pulmonary metastases from lymphomas or germ cell tumors
* No biopsy proven interstitial fibrosis, radiation induced pneumonitis, or evidence of significant pulmonary hypertension by history, radiologic, echocardiographic, or catheterization studies
* No active intracranial or leptomeningeal metastases
* Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met:
* No active disease on 2 MRIs done one month apart
* No requirement for anticonvulsant medications or steroids
* Adequate pulmonary reserve to tolerate pneumonectomy:
* Oxygen consumption greater than 50% predicted AND
* FEV1 and DLCO greater than 80% predicted OR
* FEV1 or DLCO less than 80% predicted allowed if postoperative FEV1 and DLCO is at least 40% predicted on the basis of split function V/Q scan
* Prior radiotherapy to chest allowed provided 6 months have elapsed since completion of treatment and no history of, nor current evidence of, interstitial lung disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* More than 3 months
Hematopoietic:
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
* WBC greater than 3,500/mm\^3
Hepatic:
* PT/PTT normal
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST/ALT less than 1.5 times ULN
Renal:
* Creatinine less than 1.6 mg/dL
Cardiovascular:
* Fixed defects on thallium scanning with ejection fraction greater than 40% allowed
* Reversible or ischemic defects allowed only after cardiology clearance
Pulmonary:
* See Disease Characteristics
* Resting oxygen saturation greater than 90%
* pCO\_2 less than 45 mmHg by arterial blood gas
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infections
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* More than 30 days since prior biologic therapy for this malignancy
Chemotherapy:
* More than 30 days since prior chemotherapy for this malignancy
* Prior paclitaxel allowed
* No prior bleomycin, nitrosoureas, or busulfan
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
* Prior thoracic surgery allowedReferences
Publications (0)
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