CClinicalTrials.gg
CompletedNCT00020007Updated Apr 29, 2015

Paclitaxel and Hyperthermic Perfusion in Treating Patients With Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

A Phase 1 interventional study of isolated perfusion and paclitaxel in Lung Cancer and Metastatic Cancer, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

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

02

Conditions studied

  • Lung Cancer
  • Metastatic Cancer

Browse trials for

Keywords

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 allowed
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Drugisolated perfusion
  • Drugpaclitaxel
  • Procedurehyperthermia treatment
06

Study locations

2 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • NCI - Center for Cancer Research
    Bethesda, Maryland 20892, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00020007
Lead sponsor
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Dec 1999
Last update
Apr 29, 2015

Study contacts

David S. Schrump, MD
study chair · NCI - Surgery Branch
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion