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Study of Arsenic Trioxide in Small Cell Lung Cancer

Information source: Emory University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Cancer of Lung; Pulmonary Cancer; Pulmonary Neoplasms; Carcinoma, Small Cell

Intervention: Arsenic Trioxide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Taofeek Owonikoko, MD, PhD, Principal Investigator, Affiliation: Emory University Winship Cancer Institute

Overall contact:
Taofeek Owonikoko, MD, PhD, Phone: 1-888-946-7447, Email: towonik@emory.edu

Summary

The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in patients with small cell lung cancer who have failed at least one standard chemotherapy regimen as well as patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in this patient group. The study will include up to 36 participants with small cell lung cancer.

The investigators want to find out what effects, good or bad, that the study drug has on your cancer. This study will also look at specific biomarkers in your blood and in the tumor tissue which may help the investigators to determine if the levels of these biomarkers are related to tumor response to treatment.

Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more mature thereby stopping them from growing in number and more likely to die off.

Clinical Details

Official title: A Single Arm, Two-Stage Phase II Study of Arsenic Trioxide in Previously Treated Small Cell Lung Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Response rate (RR)

Clinical Benefit Rate (CBR)

Secondary outcome:

Progression-free survival

Overall Survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed small cell lung cancer

- Patients must have measurable disease, defined as at least one lesion that can be

accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease.

- Patient must have failed or found to be intolerant of standard frontline

platinum-based regimens. There is no limit on the number of prior regimens provided the patient meets all the other eligibility criteria.

- Adult patients 18 years or older. Because no dosing or adverse event data are

currently available on the use of arsenic trioxide in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.

- Life expectancy of greater than 3 months

- ECOG performance status of 0,1 or 2

- Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count >1,500/mL

- platelets >100,000/mL

- total bilirubin ≤ 1. 5 X institutional upper limits of normal

- AST(SGOT)/ALT(SGPT) <2. 5 X institutional upper limit of normal

- creatinine ≤ 1. 5 X institutional upper limits of normal OR

- creatinine clearance >40 mL/min/1. 73 m2 for patients with

- creatinine levels above institutional normal.

- Negative serum pregnancy test within 48 hours before starting study treatment in

women with childbearing potential

- Ability to understand and the willingness to sign a written informed consent

document.

- No history of QTc prolongation syndrome or any other cardiac conduction abnormality

evidenced by normal baseline EKG (QTc ≤450 in males and ≤470 in females)

- Both men and women and members of all races and ethnic groups are eligible for this

trial.

Exclusion Criteria:

- Need for treatment with chemotherapy (within 4 weeks; 6 weeks for nitrosoureas or

mitomycin C); radiotherapy or biologic agents (within 2 weeks) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

- Patients may not be receiving any other investigational agents.

- Patients with uncontrolled symptomatic brain metastases. Patients with no known brain

metastasis are not required to undergo screening prior to enrolment.

- History of allergic reactions attributed to compounds of similar chemical or biologic

composition to arsenic trioxide.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active

infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

- Pregnant women are excluded from this study because Trisenox is a category D agent

with the potential to cause fetal harm. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Trisenox, breastfeeding should be discontinued if the mother is treated with Trisenox.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of

the potential for pharmacokinetic interactions with Trisenox. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

- Patients who require ongoing treatment with any hematopoietic colony-stimulating

growth factors (e. g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug.

- Patients who are currently receiving treatment with medication that has the potential

to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug

- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or

who have not recovered from side effects of such therapy

- History of another malignancy within 3 years, except curatively treated basal cell

carcinoma of the skin, DCIS, early stage prostate cancer without detectable PSA or excised carcinoma in situ of the cervix

- Patient is unable or unwilling to abide by the study protocol

Locations and Contacts

Taofeek Owonikoko, MD, PhD, Phone: 1-888-946-7447, Email: towonik@emory.edu

Emory University Winship Cancer Institute, Atlanta, Georgia 30322, United States; Recruiting
Taofeek Owonikoko, MD, PhD, Phone: 888-946-7447, Email: towonik@emory.edu
Additional Information

Winship Clinical Trials

Starting date: August 2011
Last updated: November 15, 2012

Page last updated: February 07, 2013

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