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Study of Arsenic Trioxide in Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470248
First Posted: November 11, 2011
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cephalon
Teva Pharmaceuticals USA
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Taofeek K. Owonikoko, Emory University
Results First Submitted: January 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lung Cancer
Cancer of Lung
Pulmonary Cancer
Pulmonary Neoplasms
Carcinoma, Small Cell
Intervention: Drug: Arsenic Trioxide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients were enrolled through the thoracic medical oncology clinic of the Winship Cancer Institute of Emory University, between August 2011 and April 2014.

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
Arsenic Trioxide Treatment

This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.

Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects


Participant Flow:   Overall Study
    Arsenic Trioxide Treatment
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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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
Arsenic Trioxide Treatment

This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.

Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects


Baseline Measures
   Arsenic Trioxide Treatment 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.40  (10.67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  35.0% 
Male      13  65.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  20.0% 
White      16  80.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate (RR)   [ Time Frame: Every 8 weeks ]

2.  Primary:   Clinical Benefit Rate (CBR)   [ Time Frame: After completing at least 1 cycle (8 weeks) of treatment ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Every 8 weeks ]

4.  Secondary:   Overall Survival   [ Time Frame: From enrolment till death on average up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Taofeek K. Owonikoko, MD, PhD, MSCR
Organization: Emory University
phone: 404-778-1900
e-mail: towonik@emory.edu


Publications of Results:

Responsible Party: Taofeek K. Owonikoko, Emory University
ClinicalTrials.gov Identifier: NCT01470248     History of Changes
Other Study ID Numbers: IRB00050301
WCI1988-11 ( Other Identifier: Other )
K23CA164015 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2011
First Posted: November 11, 2011
Results First Submitted: January 18, 2017
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017