Study of Arsenic Trioxide in Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01470248|
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : March 8, 2017
Last Update Posted : April 5, 2017
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 or disease||Intervention/treatment||Phase|
|Lung Cancer Cancer of Lung Pulmonary Cancer Pulmonary Neoplasms Carcinoma, Small Cell||Drug: Arsenic Trioxide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Two-Stage Phase II Study of Arsenic Trioxide in Previously Treated Small Cell Lung Cancer|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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
- Response Rate (RR) [ Time Frame: Every 8 weeks ]
Response rate (complete response [CR]+ partial response [PR]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
- Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
- Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Clinical Benefit Rate (CBR) [ Time Frame: After completing at least 1 cycle (8 weeks) of treatment ]Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.
- Progression-free Survival [ Time Frame: Every 8 weeks ]
Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- Overall Survival [ Time Frame: From enrolment till death on average up to 2 years ]Duration of time from enrollment on study until death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470248
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Taofeek Owonikoko, MD, PhD||Emory University Winship Cancer Institute|