Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00619021 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: gemcitabine hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | January 2003 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytologically or histologically confirmed non-small cell lung cancer meeting the following criteria:
PATIENT CHARACTERISTICS:
No medical conditions that would make this protocol unreasonably hazardous, in the opinion of the treating physician, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 6 months since prior gemcitabine hydrochloride
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Jonathan D'Cunha, MD, PhD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000586457, UMN-2002LS028, UMN-IRB-0201M15401, LILLY-UMN-2002LS028 |
Study First Received: | February 19, 2008 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00619021 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent non-small cell lung cancer stage I non-small cell lung cancer stage II non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Immunologic Factors Antiviral Agents Immunosuppressive Agents Recurrence Carcinoma Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |