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

NCT01607554 | Terminated Phase 1 Results DMC

• 2 other identifiers: INST 1201NCI-2012-01531
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung; non small cell; NSCLC; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Change in tumor size will be measured by CT scan using RECIST criteria.

  8 weeks

Secondary Outcomes (6)

• Time to Progression (TTP)

  Up to 100 months

• Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy

  1 year

• Toxicity of Irinotecan Salvage Chemotherapy

  2 days preceding each cycle of therapy

• Progression Free Survival (PFS)

  Up to 100 months

• Median Duration of Response

  Up to 100 months

Study Arms (1)

Irinotecan

EXPERIMENTAL

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.

Drug: Irinotecan

Interventions

Irinotecan DRUG

180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician

Also known as: Camptosar; Campto

Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• University of New Mexico Cancer Center: collaborator
• Lovelace Respiratory Research Institute: collaborator

Study Sites (3)

Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

Related Links

• University of New Mexico Cancer Center, an NCI Designated Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to no subjects analyzed. There will be no publication, as the original PI has left employment with the institution.

Results Point of Contact

• Title: Valerie Parks, RN
• Organization: University of New Mexico Comprehensive Cancer Center

vparks@salud.unm.edu

505-925-0390

Study Officials

• Martin J Edelman, MD

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

• Mathewos Tessema, PhD

  Lovelace Respiratory Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 30, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 22, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)