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

Phase 2

Completed

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

Interventions: Drug: Paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (vinorelbine tartrate, paclitaxel)	Paclitaxel	Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Treatment (vinorelbine tartrate, paclitaxel)	Quality-of-Life Assessment	Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Treatment (vinorelbine tartrate, paclitaxel)	Questionnaire Administration	Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Treatment (vinorelbine tartrate, paclitaxel)	Vinorelbine Tartrate	Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival.	Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events	Up to week 17	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 Based on RECIST Criteria	Up to 5 years	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

Locations (5): Great Plains Regional Medical Center
🇺🇸
North Platte, Nebraska, United States
CHI Health Saint Francis
🇺🇸
Grand Island, Nebraska, United States
Veterans Administration Medical Center, Omaha
🇺🇸
Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Avera McKennan Hospital and University Health Center
🇺🇸
Sioux Falls, South Dakota, United States