Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00602797
- Run by
- University of Nebraska
- People needed
- 20
- Starts
- 2007-12-17
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2023-09-26
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHI Health Saint Francis — Grand Island, Nebraska, United States
- Great Plains Regional Medical Center — North Platte, 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
Full record on ClinicalTrials.gov
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