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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of New Mexico Cancer Center
Lovelace Respiratory Research Institute
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01607554
First received: May 9, 2012
Last updated: September 27, 2013
Last verified: September 2013

May 9, 2012
September 27, 2013
April 2012
May 2018   (final data collection date for primary outcome measure)
Tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in tumor size will be measured by CT scan using RECIST criteria.
Tumor response will be measured by CT using modified RECIST criteria. [ Time Frame: 8 weeks after each cycle ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01607554 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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. ] [ 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 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 ] [ 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
Not Provided
Not Provided
 
Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
December 2019
May 2018   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01607554
INST 1201, NCI-2012-01531
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
  • University of New Mexico Cancer Center
  • Lovelace Respiratory Research Institute
Principal Investigator: Martin J Edelman, MD UNM Cancer Center
Principal Investigator: Mathewos Tessema, PhD Lovelace Respiratory Research Institute
New Mexico Cancer Care Alliance
September 2013

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