Overview

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

Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New Mexico Cancer Care Alliance
Collaborators:
Lovelace Respiratory Research Institute
University of New Mexico Cancer Center
Treatments:
Camptothecin
Irinotecan
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