Study of Arsenic Trioxide in Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Taofeek K. Owonikoko, Emory University
ClinicalTrials.gov Identifier:
NCT01470248
First received: October 25, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Cancer of Lung
Pulmonary Cancer
Pulmonary Neoplasms
Carcinoma, Small Cell
Drug: Arsenic Trioxide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Two-Stage Phase II Study of Arsenic Trioxide in Previously Treated Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Response rate (RR) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: After completing at least 1 cycle (8 weeks) of treatment ] [ Designated as safety issue: No ]
    Sum of CR, PR and SD in patients eligible for efficacy analysis.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From enrolment till death on average up to 2 years ] [ Designated as safety issue: No ]
    Duration of time from enrollment on study until death


Estimated Enrollment: 36
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic Trioxide Treatment
This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Drug: Arsenic Trioxide
Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects
Other Names:
  • Trisenox
  • ATO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470248

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Cephalon
Investigators
Principal Investigator: Taofeek Owonikoko, MD, PhD Emory University Winship Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Taofeek K. Owonikoko, Assistant Professor, Hematology/Medical Oncology, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01470248     History of Changes
Other Study ID Numbers: IRB00050301, WCI1988-11
Study First Received: October 25, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Lung Cancer
Carcinoma, small cell
Trisenox
Arsenic trioxide
phase II trial

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014