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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01014598
First received: November 16, 2009
Last updated: June 9, 2015
Last verified: June 2015

November 16, 2009
June 9, 2015
May 2006
May 2015   (final data collection date for primary outcome measure)
  • Acute toxicity assessed using CTCAE version 4.0 [ Time Frame: Within 7 days from lung infusion ] [ Designated as safety issue: Yes ]
  • Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT [ Time Frame: Within 30 days of the procedure ] [ Designated as safety issue: Yes ]
    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.
  • Reversibility of all toxicities from this approach. [ Time Frame: Up to 90 days from the start of lung infusion therapy ] [ Designated as safety issue: No ]
To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with unresectable lung cancer or resectable metastatic sarcoma to lung [ Time Frame: 90 days after surgery ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01014598 on ClinicalTrials.gov Archive Site
  • Lung, systemic, and pulmonary artery concentrations of cisplatin [ Time Frame: Before pulmonary artery release, at 15 minutes, and 1 hour ] [ Designated as safety issue: No ]
    Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.
  • Pulmonary function test with diffusion capacity [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: No ]
    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.
  • Split lung function test [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: No ]
    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.
To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered. [ Time Frame: 90 days after tissue is received ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis
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.

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Malignant Neoplasm in the Lung
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Adult Soft Tissue Sarcoma
  • Stage IV Non-Small Cell Lung Cancer
  • Drug: Cisplatin
    Given intra-arterially via isolated lung suffusion
    Other Names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • CISPLATIN
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Other: Pharmacological Study
    Correlative studies
Experimental: Treatment (chemotherapy)
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.
Interventions:
  • Drug: Cisplatin
  • Other: Pharmacological Study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
Not Provided
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 disease 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; generally, bulky metastatic disease causes performance impairment that would exclude the patient from being eligible because of the pulmonary and other requirements; 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)
  • 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)

Exclusion Criteria:

  • 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)
  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014598
I 70005, NCI-2009-01604, I 70005, P30CA016056
No
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Todd Demmy Roswell Park Cancer Institute
Roswell Park Cancer Institute
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP