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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Quality-of-Life Assessment
Questionnaire Administration
Vinorelbine Tartrate
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-Small Cell Lung Carcinoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHI Health Saint Francis
  • Great Plains Regional Medical Center
  • Veterans Administration Medical Center, Omaha
  • University of Nebraska Medical Center
  • Avera McKennan Hospital and University Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vinorelbine tartrate, paclitaxel)

Arm Description

Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 15, 2008
Last Updated
September 16, 2023
Sponsor
University of Nebraska
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00602797
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2007 (Actual)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
August 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vinorelbine tartrate, paclitaxel)
Arm Type
Experimental
Arm Description
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Vinorelbine Tartrate
Other Intervention Name(s)
Biovelbin, Eunades, KW-2307, Navelbine, Navelbine Ditartrate, Vinorelbine Ditartrate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression-free Survival.
Description
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 Frame
Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
Secondary Outcome Measure Information:
Title
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Description
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.
Time Frame
Up to week 17
Title
Response Rate Based on RECIST Criteria
Description
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
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apar K Ganti, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI Health Saint Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Great Plains Regional Medical Center
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69103
Country
United States
Facility Name
Veterans Administration Medical Center, Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Avera McKennan Hospital and University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27491498
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.
Results Reference
result

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

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