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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Translational Research Informatics Center, Kobe, Hyogo, Japan
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00616031
First received: February 14, 2008
Last updated: August 9, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: nitroglycerin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Adverse event and its severity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Blood concentration of paclitaxel and carboplatin immediately and two hours after the administration of the anticancer drug (paclitaxel) in the first course of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616031

Locations
Japan
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Hiroyasu Yasuda, MD, PhD    81-75-751-4770    yasuda@kuhp.kyoto-u.ac.jp   
Sponsors and Collaborators
Kyoto University
Translational Research Informatics Center, Kobe, Hyogo, Japan
Investigators
Study Chair: Hiroyasu Yasuda, MD, PhD Tohoku University
Investigator: Akiko Takeuchi Translational Research Informatics Center, Kobe, Hyogo, Japan
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00616031     History of Changes
Other Study ID Numbers: TRIC-TRIL-C0702, CDR0000584254, TRIC-C157
Study First Received: February 14, 2008
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Carboplatin
Nitroglycerin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014