TerminatedPhase 1 / Phase 2NCT01607554
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIrinotecan

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?New Mexico Cancer Research Alliance

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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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