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

April 28, 2015 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067490
  • NCI-00-C-0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on hyperthermia treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe