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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Zivena.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Zivena
ClinicalTrials.gov Identifier:
NCT00082472
First received: May 11, 2004
Last updated: April 14, 2006
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
NSCLC
Drug: Doxorubicin HCl Inhalation Solution
Drug: Docetaxel
Drug: Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zivena:

Estimated Enrollment: 30
Study Start Date: January 2004
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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082472

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

No publications provided

ClinicalTrials.gov Identifier: NCT00082472     History of Changes
Other Study ID Numbers: Dox-2a-07
Study First Received: May 11, 2004
Last Updated: April 14, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Zivena:
NSCLC
Metastatic
Unresectable
No Prior Chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Liposomal doxorubicin
Docetaxel
Cisplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014