PKCi & mTOR Inhibition With Auranofin+Sirolimus for Squamous Cell Lung Cancer
The primary purpose of this study is to find out what effects (good or bad) the drugs auranofin and sirolimus have on patients with lung cancer; to find out if auranofin and sirolimus can stop or slow the growth of the lung cancer; to learn more about how auranafin and sirolimus work against lung cancer by testing blood and tissue samples.
Adenosquamous Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Combined PKCiota and mTOR Inhibition as Maintenance Therapy for Patients With Stage IV Squamous Histology NSCLC Without Progression Following at Least Four Cycles of First-line Platinum Containing Chemotherapy|
- Progression-free survival rate measured by survival out to 4 months. [ Time Frame: At 4 months ] [ Designated as safety issue: No ]A patient is considered to be a 4-month progression-free survivor, or success, if the patient is 4 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Additionally, an estimate and confidence interval for the 4-month progression-free survival rate incorporating censoring may be computed using the method of Kaplan-Meier.
- Survival time in this population in comparison to recent historical controls (exemplified by survival of the squamous histology cohort of the Scagliotti et al trial of cisplatin with pemetrexed or gemcitabine for advanced NSCLC). [ Time Frame: Defined as the time from registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
- Overall response rate (CR or PR) [ Time Frame: Assessed at 8 week intervals up to 2 years ] [ Designated as safety issue: No ]
- Adverse Events (AE) profile and safety of the regimen using the CTCAE v4.0. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (auranofin, sirolimus)
Patients receive auranofin and sirolimus PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: auranofin
Other Name: Ridaura
I. To assess the progression-free survival at four months of patients treated with maintenance auranafin plus sirolimus after non-progression on first line platinum based chemotherapy for stage IV squamous histology non-small cell lung cancer (NSCLC).
I. To assess the overall survival in this population in comparison to recent historical controls (exemplified by survival of the squamous histology cohort of the Scagliotti et al trial of cisplatin with pemetrexed or gemcitabine for advanced NSCLC).
II. To determine the adverse events (AE) profile and safety of the regimen. III. To determine the overall response rate, per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and duration of tumor response in this population in patients with measurable disease.
I. To assess the relationship between molecular correlates and progression free survival (PFS), overall survival (OS), response and toxicity.
Patients receive auranofin and sirolimus orally (PO) on days 1-28 of each cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737502
|United States, Arizona|
|Mayo Clinic in Arizona||Recruiting|
|Scottsdale, Arizona, United States, 85259|
|Contact: Mayo Clinic Clinical Trials Office 855-776-0015|
|Principal Investigator: Helen J. Ross|
|Principal Investigator:||Helen Ross||Mayo Clinic in Arizona|