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A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer

Phase 1
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer



- To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via
bronchial artery infusion in patients with recurrent or progressive non-small cell lung


- 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

After completion of study therapy, patients are followed every 8 weeks to 3 months for up to
2 years.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion

Outcome Time Frame:

At time of dose-limiting toxicity

Safety Issue:


Principal Investigator

Jonathan D'Cunha, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455