Status:
TERMINATED
Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00619021
Start Date
January 1 2003
End Date
January 1 2009
Last Update
November 29 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455