Clinical trial NCT01607554: Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung
non small cell
NSCLC
Irinotecan
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: University of New Mexico Cancer Center
name: Lovelace Respiratory Research Institute
First posted: 2012-05-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Response
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: Up to 100 months
measure: Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy
timeFrame: 1 year
measure: Toxicity of Irinotecan Salvage Chemotherapy
timeFrame: 2 days preceding each cycle of therapy
measure: Progression Free Survival (PFS)
timeFrame: Up to 100 months
measure: Median Duration of Response
timeFrame: Up to 100 months
measure: Median Overall Survival (OS)
timeFrame: 100 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Hematology Oncology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Martin J Edelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lovelace Respiratory Research Institute
name: Mathewos Tessema, PhD
role: PRINCIPAL_INVESTIGATOR
References: