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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Drug: Vinorelbine Tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (vinorelbine tartrate, paclitaxel)<br>Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. | Drug: Paclitaxel<br>* Given IV<br>* Other names: Taxol Konzentrat;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Drug: Vinorelbine Tartrate<br>* Given IV<br>* Other names: Vinorelbine Ditartrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival. | Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions. | Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events | 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. | Up to week 17 | 
| Response Rate Based on RECIST Criteria | The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter | Up to 5 years |