Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Conditions
Recurrent Non-small Cell Lung Cancer - Stage IIIB Non-small Cell Lung Cancer - Stage IV Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: vinorelbine tartrate Type: Drug
Name: paclitaxel Type: Drug
Name: quality-of-life assessment Type: Procedure
Name: questionnaire administration Type: Other
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
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
Locations
Saint Francis Medical Center
Grand Island, Nebraska, United States
Status: Recruiting
Contact: Mehmet S. Copur - 308-398-6518 - mcopur@sfmc-gi.org
Great Plains Regional Medical Center
North Platte, Nebraska, United States
Status: Recruiting
Contact: Irfan A. Vaziri - 308-696-7864 - vazirii@mail.gprmc.com
Omaha Veterans Administration Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Apar K. Ganti - 402-995-4171 - aganti@unmc.edu
University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Apar K. Ganti - 402-559-6210 - aganti@unmc.edu
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Addison R. Tolentino - 800-657-4377 - Jan.Healy@avera.org
Start Date
December 2007
Sponsors
University of Nebraska
Source
University of Nebraska
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page