Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Nov 29, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Interventions being studied
- Drug: gemcitabine hydrochloride
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 29, 2017. Always confirm current availability with the study team.