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

Stopped early · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01607554

Run by

New Mexico Cancer Research Alliance

People needed

2

Starts

2012-04-01

Expected to finish

2013-03-01

Last updated by the study team

2018-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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:
• Total bilirubin less than or equal to 4.0 mg/dl, and
• SGOT or SGPT less than or equal to four times ULN
• Adequate renal function as defined by:
• Serum creatinine less than or equal to 1.5 x ULN

You may not qualify if…

• 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

Where it is running

• Hematology Oncology Associates — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

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