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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment 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).

Participant Flow:   Overall Study
    Treatment
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Vinorelbine Tartrate, Paclitaxel)

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


Baseline Measures
   Treatment (Vinorelbine Tartrate, Paclitaxel) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age, Customized [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   20 
   76.9  (3.6) 
[1] Age in years. Patients >70 years were eligible
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   20 
Female      4  20.0% 
Male      16  80.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed   20 
United States   20 


  Outcome Measures

1.  Primary:   Progression-free Survival.   [ Time Frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years ]

2.  Secondary:   Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events   [ Time Frame: Up to week 17 ]

3.  Secondary:   Response Rate Based on RECIST Criteria   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: aganti@unmc.edu


Publications of Results:

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