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

University of Nebraska

Status and phase

Completed

Phase 2

Conditions

Stage IV Non-Small Cell Lung Cancer

Recurrent Non-Small Cell Lung Carcinoma

Treatments

Other: Questionnaire Administration

Drug: Vinorelbine Tartrate

Drug: Paclitaxel

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00602797

NCI-2009-01584 (Registry Identifier)

P30CA036727 (U.S. NIH Grant/Contract)

0339-07-FB

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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