Clinical trial · Interventional
Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding and study drugs unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Patient receives gemcitabine 600 mg/m\^2.
- interventionNames
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patient receives gemcitabine 800 mg/m\^2.
- interventionNames
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Patient receives gemcitabine 1000 mg/m\^2.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available