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

Conditions

• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Docetaxel — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Selinexor — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Sep 30, 2015

Status verified

Oct 2015

Primary completion

Dec 31, 2018

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (docetaxel, selinexor)
  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.

Primary Outcome Measure

Progression free survival [ 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 ]