TerminatedPhase 1 / Phase 2NCT01607554

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.

Checked against the public recordLast updated May 22, 2018 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations3
SponsorNew Mexico Cancer Research Alliance
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
New Mexico Cancer Research Alliance
Interventions being studied
Drug: Irinotecan
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Hematology Oncology AssociatesAlbuquerque, New Mexico
  • University of New Mexico Cancer CenterAlbuquerque, New Mexico
  • New Mexico Cancer Care AssociatesSanta Fe, New Mexico

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 22, 2018. Always confirm current availability with the study team.

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