Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC

June 3, 2015 updated by: Susanne Arnold

A Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be 18 years of age or greater.
  • Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
  • Patients who have recurred after previous surgery and/or radiation may participate in this trial.
  • Patients may have had prior neoadjuvant or adjuvant therapy.
  • Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration.
  • Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
  • Progression after at least one prior platinum-based chemotherapy.
  • Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
  • ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
  • Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
  • Patients requiring lung radiation must have an FEV1 of > 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO.
  • Zubrod Performance Status of 0,1 or 2.

Exclusion Criteria:

  • No prior single-agent, weekly Docetaxel chemotherapy.
  • Peripheral neuropathy ≥ Grade 1.
  • Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
  • Pregnant or nursing women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Docetaxel
30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles
Radiation: Radiation
50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting.
Time Frame: continuously through treatment
continuously through treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: continuously throughout treatment
continuously throughout treatment
To investigate in an exploratory manner, the association of p53, p21^waf1/cip1, bcl-xL, bcl-2 and bax markers in pre- and post-treatment biopsies with patient response and toxicity.
Time Frame: week 1
week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susanne Arnold

Collaborators

Kentucky Lung Cancer Research Program

Investigators

  • Principal Investigator: Susanne Arnold, MD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-LUN-69-UKY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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