A Phase 1/2 interventional study of Docetaxel and Laboratory Biomarker Analysis in Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma, sponsored by Erin Bertino. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-30.
Sponsored by Erin Bertino · Phase 1/2, Interventional, and Treatment
This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and to see how well they work when given together in treating patients with squamous cell lung cancer that has come back or spread to other places in the body. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selinexor together with docetaxel may work better in treating squamous cell lung cancer.
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and determine recommended phase II dose of the combination of docetaxel and selinexor. (Phase I) II. To evaluate the efficacy as measured by progression free survival (PFS) of docetaxel and selinexor in patients with recurrent/metastatic squamous cell lung cancer. (Phase I/II)
SECONDARY OBJECTIVES:
I. To evaluate the objective tumor response rate as determined by radiographic response.
II. To evaluated the disease control rate (complete response, partial responses, and stable disease).
III. To evaluate the overall survival (OS). IV. To evaluate the safety and tolerability of single agent selinexor.
TERTIARY OBJECTIVES:
I. Lung cancer genomics sequencing panel. II. Tumor biopsy (baseline and cycle 2). III. Plasma cytokine analysis, peripheral blood ribonucleic acid (RNA) analysis.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive docetaxel intravenously (IV) on day 1 and selinexor orally (PO) twice daily (BID) on days 1, 3, 7, 9, 13, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 9 months, and then every 6 months thereafter.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
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Exclusion Criteria:
Unstable cardiovascular function:
Patients receive docetaxel IV on day 1 and selinexor PO BID on days 1, 3, 7, 9, 13, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Docetaxel · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Selinexor
Given IV
Also known as: RP56976, Taxotere, Taxotere Injection Concentrate
Correlative studies
Correlative studies
Given PO
Also known as: CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330
Progression free survival
PFS will be estimated by the method of Kaplan and Meier (KM). Appropriate one-sided 90% confidence boundary will also be calculated for the final test KM test statistic at 12 weeks.
Time frame: Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 3 years
Disease control rate (Complete Response + Partial Response + stable disease)
An analysis of disease control rate will be performed. These estimates will be accompanied by exact binomial confidence intervals as well.
Time frame: Up to 1 year
Incidence of adverse events, graded according to the National Cancer Institute CTCAE version 4.03
Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time frame: Up to 1 year
Objective response rate (complete response [CR] or partial response [PR] by RECIST)
Those who achieve PR or CR will be considered responses and the overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. These estimates will be accompanied by exact binomial confidence intervals as well.
Time frame: Up to 1 year
Overall survival
Kaplan-Meier curves will be used to estimate overall survival. Cox proportional hazards models will be further considered to explore a limited set of confounding factors.
Time frame: Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation, assessed up to 3 years
Changes in tumor suppressor protein expression levels
Tumor biopsies before and after therapy will be evaluated to assess baseline expression of tumor suppressor proteins and how change in these proteins may correspond with clinical outcomes of interest. Markers will be summarized by descriptive statistics overall and through stratified Kaplan Meier plots to explore differences in PFS. Generalized linear models will model changes in expression levels over time, with potential adjustment for confounding variables.
Time frame: Baseline to up to course 2, day 1
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Erin Bertino