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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 9, 2012
First Posted Date  ICMJE May 30, 2012
Results First Submitted Date  ICMJE March 14, 2018
Results First Posted Date  ICMJE April 13, 2018
Last Update Posted Date May 22, 2018
Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
Tumor Response [ Time Frame: 8 weeks ]
Change in tumor size will be measured by CT scan using RECIST criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
Tumor response will be measured by CT using modified RECIST criteria. [ Time Frame: 8 weeks after each cycle ]
Measurable disease by CT will be evaluated by imaging studies every 4 cycles (8 weeks) to evaluate tumor response. Imaging may occur +/- 7 days. If a tumor response is documented per RECIST criteria, then a follow up CT to confirm that response should occur no less than 4 weeks later.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • Measure time to progression (TTP) on irinotecan chemotherapy, progression free survival (PFS), median duration of response and median overall survival (OS). [ Time Frame: Every 8 weeks post treatment cycle, until progressive disease or death. ]
    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 came 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: 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

Other Name: Camptosar; Campto
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 7, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2012)
33
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-INCLUSION:

18 years of age or older Have received prior chemotherapy for histologically proven advanced non-small cell lung cancer, up to 3 prior treatments Tumors display high ISG15 (ISG15H) at screening Life expectancy of at least 12 weeks ECOG/Zubrod performance status of 0-2 Provide informed consent permission to participate

Adequate bone marrow function as follows:

1. Absolute neutrophil count of greater than or equal to 1,500 or cells/mm3, and 2) Platelet count greater than or equal to 100,000/mm3 and 3) Absence of a regular red blood cell transfusion requirement

Adequate hepatic function with:

  1. Total bilirubin less than or equal to 4.0 mg/dl, and
  2. SGOT or SGPT less than or equal to four times ULN

Adequate renal function as defined by:

1) Serum creatinine less than or equal to 1.5 x ULN

Exclusion Criteria:

Symptomatic brain metastases

Pregnant women or nursing mothers

Patients of child bearing potential must use adequate contraception.

May not be receiving other concurrent chemotherapy or radiation therapy

Severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections

Previous hypersensitivity reaction to camptothecins

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607554
Other Study ID Numbers  ICMJE INST 1201
NCI-2012-01531 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New Mexico Cancer Care Alliance
Study Sponsor  ICMJE New Mexico Cancer Care Alliance
Collaborators  ICMJE
  • University of New Mexico Cancer Center
  • Lovelace Respiratory Research Institute
Investigators  ICMJE
Principal Investigator: Martin J Edelman, MD UNM Cancer Center
Principal Investigator: Mathewos Tessema, PhD Lovelace Respiratory Research Institute
PRS Account New Mexico Cancer Care Alliance
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP