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Metastatic Malignant Neoplasm in the LungPhase 1NCT01014598

Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis

A Phase 1 study testing Cisplatin and Pharmacological Study in people with Metastatic Malignant Neoplasm in the Lung and Stage IIIB Non-Small Cell Lung Cancer, run by Roswell Park Cancer Institute at 1 site 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

This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
4 Dec 2007to 1 May 2017
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

Who may be able to join

  • Any biopsy or cytologically proven resectable or unresectable primary or secondary (metastatic) malignancy in the lung; this is defined as
  • Tumors whose only remaining residual deposits are confined to the lungs OR
  • Oligometastatic tumors with > 80% of measurable tumor volume in the target lung In both of the above situations, no clinical evidence of central nervous system (CNS) metastases can exist; oligometastatic disease is difficult to define but would, as a guideline, have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung; exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not exceed 20% of tumor volume
  • Unresectable stage IV non-small cell lung cancer (NSCLC)
  • Unresectable stage IIIB NSCLC
  • Resectable metastatic sarcoma to lung (thoracoscopically resectable)
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  • Other malignancies that meet the criteria
  • Eastern Cooperative Oncology Group performance status 0-1
  • No oxygen needs (oxygen use per standard established criteria for oxygen requirements)
  • Modified Borg dyspnea scale < 5
  • Six minute walk >= 50% of the expected distance; this will not be used as exclusion criteria if due to a reason other than respiratory per judgment of physician e.g., pain
  • Ambulatory and resting oxygen (O2) saturation > 88%
  • PPO (predicted post operative)* forced expiratory volume in one second (FEV1) >= 50% predicted
  • PPO values should be calculated for each patient
  • PPO * diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
  • PPO values should be calculated for each patient
  • PPO * vital capacity >= 50% predicted
  • PPO values should be calculated for each patient
  • Granulocytes > 1,500 ul
  • Platelets >= 100,000 ul
  • Patients must sign a study-specific consent form prior to registration
  • Tumor anatomy must allow the isolated lung suffusion in the judgment of the principal investigator (PI)

Who cannot join

  • Uncontrolled intercurrent disease
  • Prior chemotherapy for proven metastatic disease within 4 weeks
  • Evidence of pulmonary toxicity from previous or ongoing chemotherapy
  • Creatinine > 1.5 mg/dL
  • Liver enzymes > 2 times upper normal
  • Uncontrolled congestive heart failure (in judgment of the PI)
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  • Optional: ejection fraction < 40% for clinical evidence of insufficient cardiac reserve (multi gated acquisition scan [MUGA] or echocardiogram [ECHO] will be done only if indicated in the judgment of the PI)
  • Myocardial infarction or angina within past 6 months
  • Contraindications to anticoagulation
  • Hydration intolerance (e.g., uncontrolled congestive heart failure [CHF])
  • Human immunodeficiency virus positive (HIV+) on antiretroviral therapy
  • Pregnant or lactating
  • Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma
  • Previous radiation for thorax
  • Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically
  • Prior lung removal in the affected lung (would have decreased lung volume)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors

This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with any biopsy or cytologically proven resectable or unresectable primary or secondary malignancy in the lung.

SECONDARY OBJECTIVES:

  1. To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered.

II. To evaluate systemic and pulmonary artery concentrations of cisplatin during isolated lung suffusion.

OUTLINE: This is a dose-escalation study.

Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.

After completion of study treatment, patients are followed up for at least 90 days.

Medical subject headings
Carcinoma, Non-Small-Cell Lung, Sarcoma

What participants receive

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

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given intra-arterially via isolated lung suffusion

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT01014598
Study groupRoleWhat they receive
Treatment (cisplatin)ExperimentalPatients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.
Receives: Drug: Cisplatin; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity assessed using CTCAE version 4.0

    Measured: Within 7 days from lung infusion

  2. Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT

    DLT is defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A grade 3 or above adverse event shall be considered a DLT in this study if attributed to the isolated lung suffusion cisplatin dose.

    Measured: Within 30 days of the procedure

  3. Reversibility of all toxicities from this approach.

    Measured: Up to 90 days from the start of lung infusion therapy

Secondary outcomes (3)

  1. Lung, systemic, and pulmonary artery concentrations of cisplatin

    Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.

    Measured: Before pulmonary artery release, at 15 minutes, and 1 hour

  2. Pulmonary function test with diffusion capacity

    Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.

    Measured: Up to 30 days post-treatment

  3. Split lung function test

    Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.

    Measured: Up to 30 days post-treatment

Timeline

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

  1. First posted17 Nov 2009 (estimated)
  2. Study start4 Dec 2007
  3. Primary completion23 Oct 2013
  4. Study completion1 May 2017

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01014598
Sponsor's protocol ID
I 70005
Other IDs
NCI-2009-01604, I 70005
Status last verified
Jul 2022
First submitted
16 Nov 2009
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin and Pharmacological Study in people with Metastatic Malignant Neoplasm in the Lung and Stage IIIB Non-Small Cell Lung Cancer, run by Roswell Park Cancer Institute at 1 site 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?

The sponsor lists 22 inclusion and 16 exclusion criteria. 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does the primary outcome measure?

Acute toxicity assessed using CTCAE version 4.0 (time frame: Within 7 days from lung infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01014598.

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 25 Jul 2022.

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