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Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
carboplatin
nitroglycerin
paclitaxel
Sponsored by
Kyoto University
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Stage IIIB or IV disease that cannot be treated by radical irradiation
  • Tumor lesions must be objectively evaluated according to WHO criteria (maximum diameter is no shorter than twice the slice width and no shorter than 10 mm) by CT scan
  • No brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 3 months
  • Neutrophil count > 2,000/μL
  • Hemoglobin > 10.0 g/dL
  • Platelet count > 100,000/μL
  • Serum bilirubin < 2.0 mg/dL
  • ALT and AST < 100 IU/L
  • Serum creatinine < 2.0 mg/dL
  • PaO_2 ≥ 70 mm Hg

  • No cardiac problems, including any of the following:

    • Poorly controlled hypertension
    • Unstable angina
    • Congestive heart failure
    • Myocardial infarction within the past year
    • Ventricular arrhythmia that requires treatment except single, well-controlled isolated ventricular extrasystole
  • No chronic active hepatitis or cirrhosis requiring treatment except hepatitis virus carriers who do not need treatment
  • No comorbidity of interstitial pneumonia and pulmonary fibrosis requiring treatment
  • No other cancer requiring treatment except a malignant tumor curatively resected with no recurrence
  • No severe psychiatric disorders including schizophrenia or dementia
  • Cardiothoracic ratio < 60% by chest x-ray
  • No history of severe drug allergy or allergy to polyoxyethylene castor oil (in some anesthetic drugs or muscle relaxants) or polysorbate 80

  • Patients in whom nitroglycerin preparations are contraindicated are not eligible, including any of the following:

    • Severe hypotension (e.g., systolic blood pressure ≤ 80 mm Hg)
    • Angle-closure glaucoma
    • History of hypersensitivity to nitrate/nitrite ester drugs
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy

    • Pleurodesis is not considered chemotherapy
  • At least 1 week since prior and no other concurrent nitric oxide donors (e.g., nitroglycerin)
  • At least 1 week since prior and no concurrent calcium antagonists
  • At least 1 week since prior and no concurrent drugs for erectile dysfunction that inhibit phosphodiesterase 5 (e.g., sildenafil citrate or vardenafil hydrochloride hydrate)

  • More than 24 hours since prior and no concurrent administration of the following:

    • Antifungal azoles, including ketoconazole, miconazole, or itraconazole
    • Macrolides, including erythromycin or clarithromycin
    • Cyclosporines
    • Benzodiazepines, including diazepam, triazolam, or midazolam
    • Vitamin A
    • Steroid hormones, including ethinylestradiol
  • No concurrent participation in another clinical trial

Sites / Locations

  • Kyoto University HospitalRecruiting

Outcomes

Primary Outcome Measures

Tumor response rate

Secondary Outcome Measures

Progression-free survival
Adverse event and its severity
Overall survival
Change in the plasma concentration of VEGF between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Change in the number of endothelial progenitor cells in blood between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment

Full Information

First Posted
February 14, 2008
Last Updated
August 9, 2013
Sponsor
Kyoto University
Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00616031
Brief Title
Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kyoto University
Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. PURPOSE: This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer. OUTLINE: This is a multicenter, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive nitroglycerin, paclitaxel, and carboplatin. Arm II: Patients receive paclitaxel and carboplatin. In both arms, treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
nitroglycerin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Tumor response rate
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Adverse event and its severity
Title
Overall survival
Title
Change in the plasma concentration of VEGF between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Title
Change in the number of endothelial progenitor cells in blood between before and after the three-day administration of nitroglycerin prior to the start of the administration of anticancer drugs in the first course of the treatment
Title
Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIB or IV disease that cannot be treated by radical irradiation Tumor lesions must be objectively evaluated according to WHO criteria (maximum diameter is no shorter than twice the slice width and no shorter than 10 mm) by CT scan No brain metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 3 months Neutrophil count > 2,000/μL Hemoglobin > 10.0 g/dL Platelet count > 100,000/μL Serum bilirubin < 2.0 mg/dL ALT and AST < 100 IU/L Serum creatinine < 2.0 mg/dL PaO_2 ≥ 70 mm Hg No cardiac problems, including any of the following: Poorly controlled hypertension Unstable angina Congestive heart failure Myocardial infarction within the past year Ventricular arrhythmia that requires treatment except single, well-controlled isolated ventricular extrasystole No chronic active hepatitis or cirrhosis requiring treatment except hepatitis virus carriers who do not need treatment No comorbidity of interstitial pneumonia and pulmonary fibrosis requiring treatment No other cancer requiring treatment except a malignant tumor curatively resected with no recurrence No severe psychiatric disorders including schizophrenia or dementia Cardiothoracic ratio < 60% by chest x-ray No history of severe drug allergy or allergy to polyoxyethylene castor oil (in some anesthetic drugs or muscle relaxants) or polysorbate 80 Patients in whom nitroglycerin preparations are contraindicated are not eligible, including any of the following: Severe hypotension (e.g., systolic blood pressure ≤ 80 mm Hg) Angle-closure glaucoma History of hypersensitivity to nitrate/nitrite ester drugs Not pregnant or nursing PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy Pleurodesis is not considered chemotherapy At least 1 week since prior and no other concurrent nitric oxide donors (e.g., nitroglycerin) At least 1 week since prior and no concurrent calcium antagonists At least 1 week since prior and no concurrent drugs for erectile dysfunction that inhibit phosphodiesterase 5 (e.g., sildenafil citrate or vardenafil hydrochloride hydrate) More than 24 hours since prior and no concurrent administration of the following: Antifungal azoles, including ketoconazole, miconazole, or itraconazole Macrolides, including erythromycin or clarithromycin Cyclosporines Benzodiazepines, including diazepam, triazolam, or midazolam Vitamin A Steroid hormones, including ethinylestradiol No concurrent participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyasu Yasuda, MD, PhD
Organizational Affiliation
Tohoku University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Akiko Takeuchi
Organizational Affiliation
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyasu Yasuda, MD, PhD
Phone
81-75-751-4770
Email
yasuda@kuhp.kyoto-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer

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