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

NCT00619021 | Terminated Phase 1 DMC

• 2 other identifiers: 2002LS028UMN-IRB-0201M15401
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

  At time of dose-limiting toxicity

Secondary Outcomes (1)

• Local response as measured by RECIST

  Week 8

Study Arms (4)

Cohort 1

EXPERIMENTAL

Patient receives gemcitabine 600 mg/m\^2.

Drug: gemcitabine hydrochloride

Cohort 2

EXPERIMENTAL

Patient receives gemcitabine 800 mg/m\^2.

Drug: gemcitabine hydrochloride

Cohort 3

EXPERIMENTAL

Patient receives gemcitabine 1000 mg/m\^2.

Drug: gemcitabine hydrochloride

Cohort 4

EXPERIMENTAL

Patient receives gemcitabine 1200 mg/m\^2.

Drug: gemcitabine hydrochloride

Interventions

gemcitabine hydrochloride DRUG

4 dose levels designated by cohort; 600 mg/m\^2, 800 mg/m\^2, 1000 mg/m\^2, 1200 mg/m\^2

Also known as: Gemzar

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jonathan D'Cunha, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: January 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)