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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Interventions Drug: Paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Treatment (Vinorelbine Tartrate, Paclitaxel)
Hide Arm/Group Description

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

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Vinorelbine Tartrate: Given IV

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
76.9  (3.6)
[1]
Measure Description: Age in years. Patients >70 years were eligible
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Progression-free Survival.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Patients >70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Months
7.8
(1.92 to 13.56)
2.Secondary Outcome
Title Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
6
  30.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment
Comments Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).
Type of Statistical Test Other
Comments An interim analysis was conducted after 10 patients were accrued. 3/10 patients developed >grade 3 non-hematological toxicity. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.
Method of Estimation Estimation Parameter Proportion
Estimated Value 6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Response Rate Based on RECIST Criteria
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
Patients >70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  26.3%
Time Frame [Not Specified]
Adverse Event Reporting Description All cause mortality is reported for the 20 patients enrolled in the study. Adverse event and Serious adverse events reporting is out of the 19 patients that were treated on the study. One of the patients enrolled on this study deteriorated before treatment and was not treated on the study.
 
Arm/Group Title Treatment (Vinorelbine Tartrate, Paclitaxel)
Hide Arm/Group Description

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

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Vinorelbine Tartrate: Given IV

All-Cause Mortality
Treatment (Vinorelbine Tartrate, Paclitaxel)
Affected / at Risk (%)
Total   16/20 (80.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Vinorelbine Tartrate, Paclitaxel)
Affected / at Risk (%) # Events
Total   6/19 (31.58%)    
Cardiac disorders   
Cardiac arrest  1  1/19 (5.26%)  1
Infections and infestations   
Febrile neutropenia  1  2/19 (10.53%)  2
Nervous system disorders   
Ischemic encephalopathy  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Acute hypoxic respiratory failure  1  1/19 (5.26%)  1
pulmonary infiltrates  1  1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Vinorelbine Tartrate, Paclitaxel)
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  4/19 (21.05%) 
Neutropenia  1  4/19 (21.05%) 
Leukopenia  1  5/19 (26.32%) 
Lymphopenia  1  1/19 (5.26%) 
Endocrine disorders   
Hyperglycemia  1  1/19 (5.26%) 
Gastrointestinal disorders   
Bowel perforation  1  1/19 (5.26%) 
General disorders   
weakness  1  1/19 (5.26%) 
fatigue  1  1/19 (5.26%) 
Immune system disorders   
Allergic reaction  1  1/19 (5.26%) 
Infections and infestations   
Febrile neutropenia  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Anorexia  1  1/19 (5.26%) 
Hypocalcemia  1  1/19 (5.26%) 
Hyponatremia  1  1/19 (5.26%) 
Hypokalemia  1  1/19 (5.26%) 
Weight loss  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
back pain  1  2/19 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
pulmonary infiltrates  1  5/19 (26.32%) 
hypoxemia  1  5/19 (26.32%) 
Pleural effusion  1  2/19 (10.53%) 
Bronchospasm  1  1/19 (5.26%) 
Pneumothorax  1  1/19 (5.26%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Associate Director of Clinical Research
Organization: University of Nebraska Medical Center
Phone: 402-559-5622
Responsible Party: Apar Kishor Ganti, MD, 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 Submitted: January 15, 2008
First Posted: January 28, 2008
Results First Submitted: January 30, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018