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

New Mexico Cancer Care Alliance

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01607554

NCI-2012-01531 (Registry Identifier)

INST 1201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Irinotecan

Experimental group

Description:

The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.

Treatment:

Drug: Irinotecan