Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

April 14, 2006 updated by: Zivena

Phase I/II Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer

This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary Objective of Phase I

  • To determine the maximal and Phase II dose of inhaled doxorubicin HCl when given in combination with IV docetaxel and cisplatin in patients with locally advanced or metastatic unresectable NSCLC who have not been previously treated with chemotherapy.

Primary Objective of Phase II

  • To obtain preliminary evidence of therapeutic activity using imaging studies in patients with measurable or evaluable lung lesions and serial measurements of disease-related pulmonary symptoms and pulmonary function.

Secondary Objective

  • To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
      • Las Vegas, Nevada, United States, 89106
        • Southern Nevada Cancer Research Foundation
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible.
  • No prior chemotherapy or biologic therapy for lung cancer
  • Measurable or evaluable pulmonary disease required
  • Age > 18 years
  • ECOG performance status of 0-1
  • Adequate bone marrow, hepatic, and renal function
  • Total bilirubin < ULN
  • SGOT and/or SGPT may be up to 2.5 x ULN if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4 x ULN if SGOT and SGPT are both ≤ ULN
  • Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min/1.7 m2 BSA

  • Patients must have the following pulmonary function test values:

    • DLCO > 50% predicted. (DLCO must be adjusted for the patient's hemoglobin)
    • FVC> 50% of predicted
    • FEV1 >50% of predicted
    • Resting oxygen saturation > 90%
    • Exercise oxygen saturation > 85%
  • Prior surgery is permitted provided full recovery has occurred
  • Patients may not have received prior radiotherapy to the lungs. Patients with only chest wall or breast irradiation are eligible provided there is no radiographic evidence of pulmonary damage attributed to radiation therapy. Patients who have undergone Radioactive Iodine (RAI) therapy are also eligible.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

  • Women must not be pregnant or breast-feeding during this study. Men and women with reproductive potential must use an effective contraceptive method while on this study and agree to use an effective method for three months after completing chemotherapy.
  • Patients with large obstructive pulmonary lesions that may cause blockage of delivery of aerosolized drug to the affected lung, in the judgment of the treating physician. A ventilation scan is recommended if the status is unclear.
  • Patients with other active malignancies. Patients with a history of prior malignancy other than NSCLC must not have received chemotherapy within the past 5 years and may not have had prior therapy with mitomycin (> 25 mg/m2), bleomycin or nitrosoureas (> 200 mg/m2). The patient may not have had any indication of pulmonary toxicity from the chemotherapy.
  • Serious active infections which are not controlled such that the patient continues to manifest symptoms despite treatment
  • Patients with progressive extra-pulmonary metastases who are unlikely to benefit from systemic or inhaled chemotherapy, e.g., extensive liver metastases, untreated brain metastases or treated brain metastases which are not clinically stable. If patients have received radiation treatment for brain metastases, at least 3 weeks must have elapsed since the last treatment and the patient must have recovered from all toxicity, not be receiving corticosteroids and have stable neurologic function off corticosteroids.
  • Patients with known hypersensitivity to platinum compounds or taxanes or other drugs formulated with polysorbate 80
  • asthma
  • uncontrolled diabetes mellitus
  • Patients who have undergone lung transplantation
  • unstable angina, congestive heart failure, or symptomatic arrhythmias or any other serious illness or medical condition that in the judgment of the investigator compromises the patient's safety
  • clinically significant neuropathy (≥ Grade 1) by history or physical examination
  • Patients using other investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zivena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Registration Dates

First Submitted

May 11, 2004

First Submitted That Met QC Criteria

May 11, 2004

First Posted (Estimate)

May 12, 2004

Study Record Updates

Last Update Posted (Estimate)

April 18, 2006

Last Update Submitted That Met QC Criteria

April 14, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dox-2a-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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