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A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies

Phase 1
18 Years
Not Enrolling
Lung Cancer, Metastatic Cancer

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Trial Information

A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies


- Determine the maximum tolerated dose and phase II dose of paclitaxel administered via
hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary

- Determine the nature of the toxic effects of this regimen in this patient population.

- Evaluate the pharmacokinetic profile of this regimen in these patients.

- Determine the relationship between pharmacodynamic parameters and toxic effects of this
regimen in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel.

Patients undergo posterolateral thoracotomy or median sternotomy. Patients receive
paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion.
The entire surgery lasts approximately 4 hours.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

Patients are followed at 1 and 2 months. Patients with responding disease continue to be
followed every 3 months.

PROJECTED ACCRUAL: A maximum of 31 patients will be accrued for this study.

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 3 months


- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

- WBC greater than 3,500/mm^3


- PT/PTT normal

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- AST/ALT less than 1.5 times ULN


- Creatinine less than 1.6 mg/dL


- Fixed defects on thallium scanning with ejection fraction greater than 40% allowed

- Reversible or ischemic defects allowed only after cardiology clearance


- See Disease Characteristics

- Resting oxygen saturation greater than 90%

- pCO_2 less than 45 mmHg by arterial blood gas


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infections

- HIV negative


Biologic therapy:

- More than 30 days since prior biologic therapy for this malignancy


- More than 30 days since prior chemotherapy for this malignancy

- Prior paclitaxel allowed

- No prior bleomycin, nitrosoureas, or busulfan

Endocrine therapy:

- See Disease Characteristics


- See Disease Characteristics


- See Disease Characteristics

- Prior thoracic surgery allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Schrump, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • recurrent non-small cell lung cancer
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • lung metastases
  • bronchoalveolar cell lung cancer
  • pulmonary carcinoid tumor
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892