Trial Outcomes & Findings for Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer (NCT NCT01607554)
NCT ID: NCT01607554
Last Updated: 2018-05-22
Results Overview
Change in tumor size will be measured by CT scan using RECIST criteria.
TERMINATED
PHASE1/PHASE2
2 participants
8 weeks
2018-05-22
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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
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|---|---|
|
Overall Study
Disease progression
|
2
|
Baseline Characteristics
Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan
n=2 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
Change in tumor size will be measured by CT scan using RECIST criteria.
Outcome measures
| Measure |
Irinotecan
n=2 Participants
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
|
|---|---|
|
Tumor Response
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 100 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 days preceding each cycle of therapyPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 100 monthsPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Irinotecan
Serious adverse events
| Measure |
Irinotecan
n=2 participants at risk
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
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|---|---|
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Hepatobiliary disorders
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Cardiac disorders
Pericardial effusion
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Cardiac disorders
Pericardial tamponade
|
50.0%
1/2 • Number of events 1 • 7 months
|
Other adverse events
| Measure |
Irinotecan
n=2 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
White blood cell decreased
|
100.0%
2/2 • Number of events 2 • 7 months
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • Number of events 4 • 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 3 • 7 months
|
|
General disorders
Alopecia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 3 • 7 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 3 • 7 months
|
|
General disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 2 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Renal and urinary disorders
Creatinine increased
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Endocrine disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 4 • 7 months
|
|
General disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 4 • 7 months
|
|
General disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
General disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
General disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 2 • 7 months
|
|
Blood and lymphatic system disorders
INR increased
|
50.0%
1/2 • Number of events 2 • 7 months
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Renal and urinary disorders
Urinary retention
|
50.0%
1/2 • Number of events 1 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Number of events 1 • 7 months
|
Additional Information
Valerie Parks, RN
University of New Mexico Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place