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Lung CancerPhase 1NCT00020007

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

A Phase 1 study testing isolated perfusion, paclitaxel and hyperthermia treatment in people with Lung Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Metastatic Cancer
What is being tested?
isolated perfusion, paclitaxel and hyperthermia treatment
Type of treatment
Surgery or procedure
How many people
Not given
Where
2 sitesUnited States
Study dates
Dec 1999to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.

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.

Being tested
isolated perfusion, paclitaxel, hyperthermia treatment
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
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isolated perfusionDrug

  • paclitaxelDrug

  • hyperthermia treatmentProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00020007
Sponsor's protocol ID
CDR0000067490
Other IDs
NCI-00-C-0019
Status last verified
Jan 2006
First submitted
11 Jul 2001
Last updated
29 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing isolated perfusion, paclitaxel and hyperthermia treatment in people with Lung Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.

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