Trial record 1 of 1 for:    NCT01014598
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Cisplatin in Treating Patients With Lung Cancer

This study is currently recruiting participants.
Verified January 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01014598
First received: November 16, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This phase I trial is studying the side effects and best dose of cisplatin in treating patients with lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.


Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Adult Soft Tissue Sarcoma
Stage IV Non-small Cell Lung Cancer
Drug: cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT, and to assess the reversibility of all toxicities from this approach [ Time Frame: Within 30 days of the procedure ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Lung, systemic, and pulmonary artery concentrations of cisplatin; and results from the split lung function test and pulmonary function test with diffusion capacity [ Time Frame: Before pulmonary artery (PA) release, at 15 minutes, and 1 hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: May 2006
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy)
Patients receive cisplatin IV via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks for patients with sarcoma undergoing surgery after cisplatin), patients receive standard care outpatient systemic infusions.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

Detailed Description:

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 intravenously (IV) via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks for patients with sarcoma undergoing surgery after cisplatin), patients receive standard care outpatient systemic infusions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
    • 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%
  • Predicted post operative (PPO) * forced expiratory volume in one second (FEV1) >= 50% predicted
  • PPO * diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
  • PPO * vital capacity >= 50% predicted
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014598

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Todd L. Demmy         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Todd Demmy Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01014598     History of Changes
Other Study ID Numbers: I 70005, NCI-2009-01604, P30CA016056
Study First Received: November 16, 2009
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Sarcoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014