Lung CancerPhase 1NCT00619021
Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
A Phase 1 study testing gemcitabine hydrochloride in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gemcitabine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- gemcitabine hydrochloride
- Keywords
- recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Gemzar
4 dose levels designated by cohort; 600 mg/m^2, 800 mg/m^2, 1000 mg/m^2, 1200 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patient receives gemcitabine 600 mg/m^2. Receives: Drug: gemcitabine hydrochloride |
| Cohort 2 | Experimental | Patient receives gemcitabine 800 mg/m^2. Receives: Drug: gemcitabine hydrochloride |
| Cohort 3 | Experimental | Patient receives gemcitabine 1000 mg/m^2. Receives: Drug: gemcitabine hydrochloride |
| Cohort 4 | Experimental | Patient receives gemcitabine 1200 mg/m^2. Receives: Drug: gemcitabine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
Measured: At time of dose-limiting toxicity
Secondary outcomes (1)
Local response as measured by RECIST
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Funding and study drugs unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan D'Cunha, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619021
- Sponsor's protocol ID
- 2002LS028
- Other IDs
- UMN-IRB-0201M15401
- Status last verified
- Nov 2017
- First submitted
- 19 Feb 2008
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00619021
- Acronym / sponsor ID
- 2002LS028
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding and study drugs unavailable
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: gemcitabine hydrochloridePatient receives gemcitabine 600 mg/m^2. |
| Cohort 2 | Experimental | Drug: gemcitabine hydrochloridePatient receives gemcitabine 800 mg/m^2. |
| Cohort 3 | Experimental | Drug: gemcitabine hydrochloridePatient receives gemcitabine 1000 mg/m^2. |
| Cohort 4 | Experimental | Drug: gemcitabine hydrochloridePatient receives gemcitabine 1200 mg/m^2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Cytologically or histologically confirmed non-small cell lung cancer meeting the following criteria:
- 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochlorideAlso: Gemzar4 dose levels designated by cohort; 600 mg/m^2, 800 mg/m^2, 1000 mg/m^2, 1200 mg/m^2 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
Time frame: At time of dose-limiting toxicity
1 secondary outcome
Local response as measured by RECIST
Time frame: Week 8
Results and safety
The study was stopped early (reason given: Funding and study drugs unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D'Cunha, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemcitabine hydrochloride in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding and study drugs unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion (time frame: At time of dose-limiting toxicity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.