Clinical trial NCT00602797: Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Official title: Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival.
timeFrame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
Secondary outcomes:
measure: Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
timeFrame: Up to week 17
measure: Response Rate Based on RECIST Criteria
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Grand Island
country: United States
facility: CHI Health Saint Francis
state: Nebraska
city: North Platte
country: United States
facility: Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Veterans Administration Medical Center, Omaha
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital and University Health Center
state: South Dakota
Study officials:
affiliation: University of Nebraska
name: Apar K Ganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.