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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 : May 22, 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
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Irinotecan
Hide Arm/Group Description

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

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Disease progression             2
Arm/Group Title Irinotecan
Hide Arm/Group Description

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Tumor Response
Hide Description Change in tumor size will be measured by CT scan using RECIST criteria.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Both participants experienced an increase in tumor size between the time of the baseline CT scan and the first study CT scan. There will be no publication or further data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event.
Time Frame Up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected on this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy
Hide Description Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity of Irinotecan Salvage Chemotherapy
Hide Description Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03
Time Frame 2 days preceding each cycle of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Median Duration of Response
Hide Description [Not Specified]
Time Frame Up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description [Not Specified]
Time Frame 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.
Arm/Group Title Irinotecan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Irinotecan
Hide Arm/Group Description

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

All-Cause Mortality
Irinotecan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Irinotecan
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Cardiac disorders   
Pericardial effusion  1/2 (50.00%)  1
Pericardial tamponade  1/2 (50.00%)  1
Hepatobiliary disorders   
Alanine aminotransferase increased  1/2 (50.00%)  1
Aspartate aminotransferase increased  1/2 (50.00%)  1
Vascular disorders   
Hypotension  1/2 (50.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, NCI v4.01
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Irinotecan
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
White blood cell decreased  2/2 (100.00%)  2
Lymphocyte count decreased  2/2 (100.00%)  3
Anemia  1/2 (50.00%)  3
INR increased  1/2 (50.00%)  2
Cardiac disorders   
Paroxysmal atrial tachycardia  1/2 (50.00%)  1
Sinus tachycardia  1/2 (50.00%)  1
Endocrine disorders   
Hyperglycemia  1/2 (50.00%)  4
Gastrointestinal disorders   
Vomiting  2/2 (100.00%)  4
Diarrhea  2/2 (100.00%)  3
Abdominal pain  1/2 (50.00%)  1
Constipation  1/2 (50.00%)  1
Gastroesophageal reflux disease  1/2 (50.00%)  1
General disorders   
Alopecia  1/2 (50.00%)  1
Anorexia  1/2 (50.00%)  1
Hypoalbuminemia  2/2 (100.00%)  4
Hypokalemia  1/2 (50.00%)  1
Hyponatremia  1/2 (50.00%)  1
Hypophosphatemia  1/2 (50.00%)  2
Non-cardiac chest pain  1/2 (50.00%)  1
Pain  1/2 (50.00%)  1
Hepatobiliary disorders   
Alanine aminotransferase increased  1/2 (50.00%)  1
Alkaline phosphatase increased  1/2 (50.00%)  1
Aspartate aminotransferase increased  1/2 (50.00%)  2
Renal and urinary disorders   
Creatinine increased  1/2 (50.00%)  1
Urinary retention  1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1/2 (50.00%)  1
Wheezing  1/2 (50.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, NCI v4.01
Early termination leading to no subjects analyzed. There will be no publication, as the original PI has left employment with the institution.
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
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: May 22, 2018