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

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ClinicalTrials.gov Identifier: NCT00602797
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Apar Kishor Ganti, MD, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Recurrent Non-Small Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer Drug: Paclitaxel Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Vinorelbine Tartrate Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : December 2007
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Vinorelbine Tartrate
Given IV
Other Names:
  • Biovelbin
  • Eunades
  • KW-2307
  • Navelbine
  • Navelbine Ditartrate
  • Vinorelbine Ditartrate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602797


Locations
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
Omaha Veterans Administration Medical Center
Omaha, Nebraska, United States, 68105
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Investigators
Principal Investigator: Apar Ganti University of Nebraska

Publications of Results:
Responsible Party: Apar Kishor Ganti, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00602797     History of Changes
Other Study ID Numbers: 339-07
NCI-2009-01584 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
339-07 ( Other Identifier: University of Nebraska Medical Center )
P30CA036727 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Vinorelbine
Vinblastine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action