Lung Cancer Clinical Trial
Official title:
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
Verified date | November 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Response Evaluation Criteria In Solid Tumors (RECIST) criteria - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Life expectancy = 12 weeks - Hemoglobin = 9.0 g/dL - Absolute neutrophil count (ANC) = 1,500/mm³ - Platelet count = 100,000/mm³ - Serum creatinine = 3.0 mg/dL - Total bilirubin < 1.5 times upper limit of normal - International normalized ratio (INR) = 1.3 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective non-hormonal contraception Exclusion Criteria: - 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 - 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 - 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) - 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 - More than 6 months since prior gemcitabine hydrochloride - More than 2 weeks since other prior chemotherapy - More than 4 weeks since prior radiotherapy |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion | At time of dose-limiting toxicity | ||
Secondary | Local response as measured by RECIST | Week 8 |
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