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
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Irinotecan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Non-Randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced, Non-Small Cell Lung Cancer With High ISG 15 Expression|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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.
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
Other Name: Camptosar; Campto
- Tumor Response [ Time Frame: 8 weeks ]Change in tumor size will be measured by CT scan using RECIST criteria.
- Time to Progression (TTP) [ Time Frame: Up to 100 months ]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.
- Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy [ Time Frame: 1 year ]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.
- Toxicity of Irinotecan Salvage Chemotherapy [ Time Frame: 2 days preceding each cycle of therapy ]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
- Progression Free Survival (PFS) [ Time Frame: Up to 100 months ]
- Median Duration of Response [ Time Frame: Up to 100 months ]
- Median Overall Survival (OS) [ Time Frame: 100 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607554
|United States, New Mexico|
|Hematology Oncology Associates|
|Albuquerque, New Mexico, United States, 87106|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|New Mexico Cancer Care Associates|
|Santa Fe, New Mexico, United States, 87505|
|Principal Investigator:||Martin J Edelman, MD||UNM Cancer Center|
|Principal Investigator:||Mathewos Tessema, PhD||Lovelace Respiratory Research Institute|