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Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
This study has been suspended.
First Received: February 19, 2008   Last Updated: April 18, 2009   History of Changes
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00619021
  Purpose

RATIONALE: Bronchial artery infusion uses a catheter to deliver antitumor substances directly to the lungs. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gemcitabine in different ways may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given by bronchial artery infusion and to see how well it works in treating patients with recurrent or progressive non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Local response as measured by RECIST [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2003
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via bronchial artery infusion in patients with recurrent or progressive non-small cell lung cancer.

Secondary

  • To evaluate local response in patients treated with this therapy.
  • To characterize the pharmacokinetics of gemcitabine hydrochloride in patients treated with this therapy.

OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride delivered via bronchial artery infusion.

Patients receive gemcitabine hydrochloride via bronchial artery infusion over 30-60 minutes on day 1 and via IV infusion over 30 minutes on day 8 of course 1. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of all subsequent courses. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks to 3 months for up to 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Cytologically or histologically confirmed non-small cell lung cancer meeting the following criteria:

    • No T2 lesions invading the visceral pleura, causing atelectasis, or proximal to an obstructing pneumonia
    • No T3 lesions invading the chest wall (including the parietal pleura, musculature, and/or rib), mediastinal pleura, diaphragm, or pericardium
    • No T4 lesions invading the heart, great vessels, carina, or esophagus
  • Must have disease that is incurable by standard treatment, defined as a minimum of first-line therapy with a platinum-containing regimen and second-line therapy with docetaxel, pemetrexed disodium, or erlotinib hydrochloride
  • Measurable or nonmeasurable disease as defined by RECIST criteria
  • No superior vena cava syndrome or superior sulcus tumors
  • Patients with airway obstructing lesions, or patients experiencing hemoptysis, dyspnea, chest pain, and/or copious sputum production may be eligible after careful consideration by the study physicians

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum creatinine ≤ 3.0 mg/dL
  • Total bilirubin < 1.5 times upper limit of normal
  • INR ≤ 1.3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, stage I carcinoma of the prostate with normal PSA, or other cancer from which the patient has been disease free for 3 years
  • No medical conditions that would make this protocol unreasonably hazardous, in the opinion of the treating physician, including any of the following:

    • Uncontrolled infection (including HIV)
    • Poorly controlled diabetes mellitus
    • Active cardiac disease (i.e., unstable angina, myocardial infarction within the past 6 months, or congestive heart failure)
  • No other serious medical illness that would limit survival to < 3 months, or psychiatric condition that would prevent informed consent, unless a legal guardian is available
  • Must consent to participate in the laboratory study, "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" during course 1

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior gemcitabine hydrochloride

    • More than 2 weeks since other prior chemotherapy
  • More than 4 weeks since prior radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619021

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Jonathan D'Cunha, MD, PhD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000586457, UMN-2002LS028, UMN-IRB-0201M15401, LILLY-UMN-2002LS028
Study First Received: February 19, 2008
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00619021     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Antiviral Agents
Immunosuppressive Agents
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009