Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Nebraska
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Apar Kishor Ganti, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00602797
First received: January 15, 2008
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with advanced non-small cell lung cancer. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells.


Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: vinorelbine tartrate
Drug: paclitaxel
Procedure: quality-of-life assessment
Other: questionnaire administration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate time to event distributions.

  • Non-hematological toxicity [ Time Frame: Up to week 17 ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.

  • Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria.


Estimated Enrollment: 29
Study Start Date: December 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (vinorelbine tartrate, paclitaxel)
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Drug: vinorelbine tartrate
Given IV
Other Names:
  • Eunades
  • navelbine ditartrate
  • NVB
  • VNB
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

Detailed Description:

OBJECTIVES:

I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer.

II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer.

III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine.

OUTLINE:

Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
  • Measurable disease on imaging studies in 2 dimensions
  • No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
  • Patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
  • Patients with other prior malignancies will be included, provided they have been disease-free for at least five years
  • Patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible
  • Karnofsky score >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2)
  • White blood cell (WBC) count >= 3,500/mm^3, OR
  • Absolute neutrophil count (ANC) >= 1,500/ul
  • Platelet count >= 100,000/mm^3
  • Serum creatinine less than 1.5 times the upper limits of normal
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal
  • Serum alkaline phosphatase less than 2.5 times the upper limits of normal
  • No active serious infections or other condition precluding chemotherapy
  • Non-pregnant and non-nursing
  • Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
  • Able to give informed consent
  • Able to return for treatment and follow-up as specified in the protocol

Exclusion Criteria:

  • Known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
  • Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
  • Inability to fulfill the requirements of the protocol
  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: NCT00602797

Locations
United States, Nebraska
Saint Francis Medical Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Mehmet S. Copur    308-398-6518    mcopur@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
Great Plains Regional Medical Center Recruiting
North Platte, Nebraska, United States, 69103
Contact: Irfan A. Vaziri    308-696-7864    vazirii@mail.gprmc.com   
Principal Investigator: Irfan A. Vaziri         
Omaha Veterans Administration Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Apar K. Ganti    402-995-4171    aganti@unmc.edu   
Principal Investigator: Apar K. Ganti         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Apar K. Ganti    402-559-6210    aganti@unmc.edu   
Principal Investigator: Apar K. Ganti         
United States, South Dakota
Avera McKennan Hospital and University Health Center Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Addison R. Tolentino    800-657-4377    Jan.Healy@avera.org   
Principal Investigator: Addison R. Tolentino         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Apar Ganti University of Nebraska
  More Information

No publications provided

Responsible Party: Apar Kishor Ganti, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00602797     History of Changes
Other Study ID Numbers: 339-07, NCI-2009-01584, 339-07, P30CA036727
Study First Received: January 15, 2008
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014