Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer - Full Text View

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 hydrochloride Gemcitabine

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:	October 2005
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	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jonathan D'Cunha, MD, PhD

Masonic Cancer Center, University of Minnesota

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000586457, UMN-2002LS028, UMN-IRB-0201M15401, LILLY-UMN-2002LS028
Study First Received:	February 19, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00619021
Health Authority:	Unspecified

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
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gemcitabine
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009