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

September 16, 2023 updated by: University of Nebraska

Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • North Platte, Nebraska, United States, 69103
        • Great Plains Regional Medical Center
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68105
        • Veterans Administration Medical Center, Omaha
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital and University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment (vinorelbine tartrate, paclitaxel)
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Vinorelbine Tartrate
Given IV
Other Names:
  • Navelbine
  • Eunades
  • Biovelbin
  • KW-2307
  • Navelbine Ditartrate
  • Vinorelbine Ditartrate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival.
Time Frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Time Frame: Up to week 17
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
Response Rate Based on RECIST Criteria
Time Frame: Up to 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Apar K Ganti, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0339-07-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • NCI-2009-01584 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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