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Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01607554
Recruitment Status : Terminated (Inadequate enrollment (2 subjects in 4 years))
First Posted : May 30, 2012
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborators:
University of New Mexico Cancer Center
Lovelace Respiratory Research Institute
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Irinotecan

  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
Irinotecan

The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.

Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle

Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician


Participant Flow:   Overall Study
    Irinotecan
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 
Disease progression                2 



  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
Irinotecan

The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.

Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle

Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 – 16 mg, both administered intravenously. Atropine 0.25 – 0.5 mg subcutaneously or IV is at the discretion of the treating physician


Baseline Measures
   Irinotecan 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   Tumor Response   [ Time Frame: 8 weeks ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Up to 100 months ]

3.  Secondary:   Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy   [ Time Frame: 1 year ]

4.  Secondary:   Toxicity of Irinotecan Salvage Chemotherapy   [ Time Frame: 2 days preceding each cycle of therapy ]

5.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 100 months ]

6.  Secondary:   Median Duration of Response   [ Time Frame: Up to 100 months ]

7.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 100 months ]


  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
Early termination leading to no subjects analyzed. There will be no publication, as the original PI has left employment with the institution.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Valerie Parks, RN
Organization: University of New Mexico Comprehensive Cancer Center
phone: 505-925-0390
e-mail: vparks@salud.unm.edu



Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01607554     History of Changes
Other Study ID Numbers: INST 1201
NCI-2012-01531 ( Registry Identifier: NCI CTRP )
First Submitted: May 9, 2012
First Posted: May 30, 2012
Results First Submitted: March 14, 2018
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018