Lung Cancer Clinical Trial
Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Summary
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. 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, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.
Full Description
PRIMARY 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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 5 Locations for this study
Grand Island Nebraska, 68803, United States
North Platte Nebraska, 69103, United States
Omaha Nebraska, 68105, United States
Omaha Nebraska, 68198, United States
Sioux Falls South Dakota, 57105, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.