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Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

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ClinicalTrials.gov Identifier: NCT00693992
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : February 2, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Interventions: Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Sunitinib Malate)

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO
Arm II (Placebo)

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies

Participant Flow:   Overall Study
    Arm I (Sunitinib Malate)   Arm II (Placebo)
STARTED   106   104 
COMPLETED   106   104 
NOT COMPLETED   0   0 



  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
Arm I (Sunitinib Malate)

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Sunitinib Malate: Given PO
Arm II (Placebo)

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Quality-of-Life Assessment: Ancillary studies
Total Total of all reporting groups

Baseline Measures
   Arm I (Sunitinib Malate)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 106   104   210 
Age 
[Units: Years]
Median (Full Range) 		 65 
 (25 to 84)  		 67 
 (44 to 89)  		 66 
 (25 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      49  46.2%      44  42.3%      93  44.3% 
Male      57  53.8%      60  57.7%      117  55.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      3   2.9%      3   1.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      18  17.0%      13  12.5%      31  14.8% 
White      87  82.1%      85  81.7%      172  81.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.9%      3   2.9%      4   1.9% 
Region of Enrollment 
[Units: Participants]
 		     
United States   106   104   210 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Time from randomization to death (up to 5 years) ]
  Show Outcome Measure 2

3.  Secondary:   Response Rate (RR)   [ Time Frame: Duration of treatment (up to 5 years) ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale   [ Time Frame: At 3 months ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale   [ Time Frame: At 3 months ]
  Show Outcome Measure 5

6.  Secondary:   Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Duration of study (up to 5 years) ]
  Show Outcome Measure 6

7.  Other Pre-specified:   VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS   [ Time Frame: Up to 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark A. Socinski, M.D.
Organization: University of Pittsburgh
e-mail: socinskima@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00693992     History of Changes
Obsolete Identifiers: NCT01647087
Other Study ID Numbers: NCI-2009-00469
NCI-2009-00469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000597649
CALGB 30607 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-30607 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2008
First Posted: June 9, 2008
Results First Submitted: December 8, 2016
Results First Posted: February 2, 2017
Last Update Posted: August 10, 2017