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AzTrials

Lung CancerPhase 1NCT00004930

Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

A Phase 1 study testing doxorubicin hydrochloride in people with Lung Cancer and Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center 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. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases. 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?
doxorubicin hydrochloride
How many people
Not given
Where
2 sitesUnited States
Study dates
Jul 1999to Feb 2004
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 confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery
  • Bronchoalveolar cell lung cancer allowed
  • Lung metastases from soft tissue sarcoma allowed
  • No leukemia or lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 160,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 1.0 mg/dL
  • AST/ALT less than 1.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.2 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • LVEF normal by MUGA scan or echocardiography
  • No unstable angina
  • No congestive heart failure
  • No symptomatic arrhythmias

Pulmonary:

  • DLCO at least 65% of normal
  • FVC at least 50% predicted
  • FEV1 at least 50% predicted
  • Resting oxygen saturation at least 90%
  • Exercise oxygen saturation at least 85%
  • No complete atelectasis
  • No asthma

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal
  • No other concurrent illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior bleomycin or nitrosoureas
  • No prior mitomycin greater than 25 mg/m^2
  • No prior anthracyclines greater than 450 mg/m^2
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy
  • Patients with only chest wall or primary breast radiation are eligible
  • No concurrent thoracic irradiation

Surgery:

  • See Disease Characteristics
  • No prior pneumonectomy

Other:

  • No daily or as necessary respiratory drugs via inhaler or nebulizer
  • No other concurrent experimental drugs

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung.
  • Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population.
  • Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
  • Obtain preliminary evidence of therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period.

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

Patients are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

Keywords
recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, lung metastases, bronchoalveolar cell lung cancer
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.

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 startJul 1999
  3. Primary completionFeb 2004
  4. Study completionFeb 2004

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
NCT00004930
Sponsor's protocol ID
99-049
Other IDs
CDR0000067614, BMI-98-DOX-001, NCI-G00-1696
Status last verified
Jun 2013
First submitted
7 Mar 2000
Last updated
19 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing doxorubicin hydrochloride in people with Lung Cancer and Metastatic Cancer, run by Memorial Sloan Kettering Cancer Center 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 19 Jun 2013. 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?

On the ClinicalTrials.gov record for NCT00004930.

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 19 Jun 2013.

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