Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 26, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Nebraska
- Interventions being studied
- Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vinorelbine Tartrate
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CHI Health Saint FrancisGrand Island, Nebraska
- Great Plains Regional Medical CenterNorth Platte, Nebraska
- Veterans Administration Medical Center, OmahaOmaha, Nebraska
- University of Nebraska Medical CenterOmaha, Nebraska
- Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 26, 2023. Always confirm current availability with the study team.