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

This study is currently recruiting participants.
Verified on August 2011 by University of Nebraska

First Received on January 15, 2008.  
Last Updated on August 8, 2011  
History of Changes
This Clinical Trial Sponsored By: University of Nebraska
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00602797
 

Purpose for Clinical Trial

RATIONALE: 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 more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving vinorelbine tartrate together with paclitaxel works in treating older patients with advanced non-small cell lung cancer

Condition Study Intervention Clinical Trial 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 II

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Paclitaxel
Vinorelbine
Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures For Clinical Trial:

  • Progression-free survival [ Time Frame: Every 3 months for 2 years and then every 6 months for 5 years ] [ Designated as safety issue: No ]
    Defined as the time from 1st therapy until first documentation of clinical progression or relapse or death. The Kaplan-Meier method will be used to estimate time to event distributions.

  • Safety [ Time Frame: At weeks 4, 9, 12 and 17 ] [ Designated as safety issue: Yes ]
    Interim monitoring after 10 patients and 19 patients have completed study. Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 must be used to grade the severity of adverse events (AEs).

  • Response rate [ Time Frame: After each cycle based on RECIST criteria ] [ Designated as safety issue: No ]
    The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

  • Quality of life [ Time Frame: At baseline and weeks 9 and 17 ] [ Designated as safety issue: No ]
    QOL will be assessed by Functional Assessment of Cancer Therapy – Lung (FACT-L) version 4.0 questionnaire.

Estimated Enrollment: 29
Study Start Date: December 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Treatment (chemotherapy): Experimental

Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Study Interventions:
  • Drug: vinorelbine tartrate
  • Drug: paclitaxel
  • Procedure: quality-of-life assessment
  • Other: questionnaire administration
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

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