Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and other agents. There is a factor called ISG15 which might help doctors better identify patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases. Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in cell growth, and it has been FDA approved for 17 years for another type of cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change in tumor size will be measured by CT scan using RECIST criteria.
- Time to progression (TTP) [ Time Frame: Up to 100 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Median duration of response [ Time Frame: Up to 100 months ] [ Designated as safety issue: No ]
- Median overall survival (OS) [ Time Frame: 100 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
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
The goal of this trial is to demonstrate the potential clinical benefit of targeted irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is associated with increased sensitivity to this drug, ISG15H.
Please refer to this study by its ClinicalTrials.gov identifier: 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|