A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- gemcitabine hydrochloride
- Conditions
- Lung Cancer
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Cohort 1
Patient receives gemcitabine 600 mg/m\^2.
Intervention: gemcitabine hydrochloride
Cohort 2
Patient receives gemcitabine 800 mg/m\^2.
Intervention: gemcitabine hydrochloride
Cohort 3
Patient receives gemcitabine 1000 mg/m\^2.
Intervention: gemcitabine hydrochloride
Cohort 4
Patient receives gemcitabine 1200 mg/m\^2.
Intervention: gemcitabine hydrochloride
Outcomes
Primary Outcomes
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
Time Frame: At time of dose-limiting toxicity
Secondary Outcomes
- Local response as measured by RECIST(Week 8)