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Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center at University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Patient receives gemcitabine 600 mg/m^2.

Patient receives gemcitabine 800 mg/m^2.

Patient receives gemcitabine 1000 mg/m^2.

Patient receives gemcitabine 1200 mg/m^2.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local response as measured by RECIST

Full Information

First Posted
February 19, 2008
Last Updated
November 27, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00619021
Brief Title
Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
Official Title
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Funding and study drugs unavailable
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patient receives gemcitabine 600 mg/m^2.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patient receives gemcitabine 800 mg/m^2.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patient receives gemcitabine 1000 mg/m^2.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Patient receives gemcitabine 1200 mg/m^2.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar
Intervention Description
4 dose levels designated by cohort; 600 mg/m^2, 800 mg/m^2, 1000 mg/m^2, 1200 mg/m^2
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Local response as measured by RECIST
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D'Cunha, MD, PhD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bronchial Artery Infusion of Gemcitabine in Treating Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

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