Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
3 other identifiers
interventional
20
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2007
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2007
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
May 17, 2018
CompletedSeptember 26, 2023
September 1, 2023
6.6 years
January 15, 2008
January 30, 2018
September 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Up to week 17
Response Rate Based on RECIST Criteria
Up to 5 years
Study Arms (1)
Treatment (vinorelbine tartrate, paclitaxel)
EXPERIMENTALPatients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Interventions
Given IV
Ancillary studies
Given IV
Eligibility Criteria
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
- +3 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Great Plains Regional Medical Center
North Platte, Nebraska, 69103, United States
Veterans Administration Medical Center, Omaha
Omaha, Nebraska, 68105, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Related Publications (1)
Huerter MM, Meza JL, Copur MS, Tolentino A, Marr AS, Ketcham M, DeSpiegelaere H, Kruse S, Kos ME, Swenson K, Radniecki SE, Kessinger A, Ganti AK. Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. J Geriatr Oncol. 2017 Jan;8(1):18-22. doi: 10.1016/j.jgo.2016.07.006. Epub 2016 Aug 1.
PMID: 27491498RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Apar Ganti
- Organization
- University of Nebraska Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Apar K Ganti, MD
University of Nebraska
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
December 17, 2007
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
September 26, 2023
Results First Posted
May 17, 2018
Record last verified: 2023-09