Topics

Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer

2015-09-01 23:38:24 | BioPortfolio

Summary

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.

Description

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.

Study Design

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

Conditions

Recurrent Squamous Cell Lung Carcinoma

Intervention

Docetaxel, Laboratory Biomarker Analysis, Pharmacological Study, Selinexor

Location

Ohio State University Comprehensive Cancer Center
Columbus
Ohio
United States
43210

Status

Not yet recruiting

Source

Ohio State University Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-01T23:38:24-0400

Clinical Trials [4276 Associated Clinical Trials listed on BioPortfolio]

AEG35156 and Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 ...

Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It ...

Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tu...

Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)

This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant...

VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recur...

PubMed Articles [36629 Associated PubMed Articles listed on BioPortfolio]

Pilot study of docetaxel combined with lobaplatin or gemcitabine for recurrent and metastatic breast cancer.

This study evaluated the efficacy and safety of docetaxel combined with lobaplatin, relative to docetaxel combined with gemcitabine, for treating patients with recurrent metastatic breast cancer (rMBC...

Exportin 1 inhibition induces nerve growth factor receptor expression to inhibit the NF-kB pathway in preclinical models of pediatric high-grade glioma.

High-grade glioma (HGG) is the leading cause of cancer death among children. Selinexor, an orally bioavailable, reversible inhibitor of the nuclear export protein, exportin 1, is in clinical trials fo...

Exposure to Docetaxel in the Elderly Patient Population: a Population Pharmacokinetic Study.

Docetaxel is commonly used in elderly patients, who are frequently diagnosed with prostate cancer. Although previous studies revealed no clinically relevant impact of older age on docetaxel pharmacoki...

Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small cell lung cancer.

Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G)in patients treated with the epidermal growth factor receptor (EGFR)-tyr...

Multicenter study of primary systemic therapy with docetaxel, cyclophosphamide and trastuzumab for HER2-positive operable breast cancer: the JBCRG-10 study.

The original aim of this study was to evaluate the treatment sequence and anthracycline requirement in docetaxel, cyclophosphamide and trastuzumab therapy. After one death in the anthracycline-contain...

Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.

A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.

More From BioPortfolio on "Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial