Phase I study of isolated lung perfusion with paclitaxel and moderate hyperthermia in patients with unresectable pulmonary malignancies

Originating Group

Thoracic Oncology Section, Surgery Branch, NCI, Bethesda MD

P.I.: Dr. David S. Schrump

Participating Groups

None

Objectives

1. To establish maximum tolerated dose and Phase II dosage of paclitaxel administered via hyperthermic retrograde isolated lung perfusion (ILuP) in patients with unresectable pulmonary malignancies.
2. To define the nature of the toxic effects of paclitaxel administered by retrograde hyperthermic ILuP.
3. To evaluate the pharmacokinetic profile of paclitaxel in lung tissues and blood when this drug is administered by retrograde hyperthermic ILuP. The relationship between pharmacodynamic parameters and toxicities will be examined.

Eligibility

1. Unresectable primary lung cancer or pulmonary metastases. Patients with bilateral metastases may be considered for staged lung perfusions. Patients with unresectable bronchoalveolar carcinomas, or previously treated primary lung cancer may be considered for ILuP. Patients with prior thoracic surgery are for study.
2. Patients may have disease outside the confines of the thorax, provided the bulk of the disease in the chest is the greatest threat to their survival.
3. Life expectancy greater than three months.
4. Patients must be 18 years of age or older.
5. No chemotherapy, or bioligic therapy within 30 days prior to the lung perfusion.
6. No radiation therapy to the chest within six months and no history of nor current evidence of interstitial lung disease.
7. ECOG performance status of 0-1.
8. Patients must have adequate pulmonary reserve evidenced by pulmonary function tests to tolerate pneumonectomy, a resting oxygen saturation greater than 90%, a normal Aa (alveolar-arterial) gradient and a pCO2 less than 45 mmHg by arterial blood gas.
9. Platelet count greater than 100,000, Hgb greater than 10gm.dl, WBC greater than 3,500/ml, normal PT/PTT, and adequate hepatic function as evidenced by a total bilirubin, and AST and ALT less than 1.5 times ULN. Creatnine must be less than 1.6.
10. Patients must be willing to sign an informed consent indicating that they are aware of the neoplastic nature of their illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks.

Schema

Not Available

Comments

Activated 12/1999

Target Accrual 39 patients

Accrual 0/39 as of 12/1999