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

Stage IV Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602797
• Other study ID #: 0339-07-FB
• Secondary ID: NCI-2009-01584P3
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2007
• Est. completion date: August 1, 2014

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2014
• Est. primary completion date: August 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Intervention

Drug:
• Paclitaxel
Given IV

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Drug:
• Vinorelbine Tartrate
Given IV

Locations

Country	Name	City	State
United States	CHI Health Saint Francis	Grand Island	Nebraska
United States	Great Plains Regional Medical Center	North Platte	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Veterans Administration Medical Center, Omaha	Omaha	Nebraska
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events	Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.	Up to week 17
Secondary	Response Rate Based on RECIST Criteria	The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter	Up to 5 years