Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

March 13, 2018 updated by: Leo W. Jenkins Cancer Center

Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES Primary

  1. Overall survival
  2. Tumor response using RECIST criteria

Secondary

  1. Determine the toxicity of the proposed treatment in this patient population.
  2. Progression free survival
  3. Locoregional control
  4. Distant failure

STUDY DESIGN

Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer.

Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination.

Outcome Measures Primary Outcome Measures

  1. Overall survival
  2. Tumor response using RECIST criteria

Secondary Outcome Measures

  1. Locoregional control
  2. Distant Failure
  3. Progression free survival

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

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
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at East Carolina University

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:

  1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.

  2. Patients will be included in the study based on the following criteria:

    • Patients must be older than 18 years old.
    • Patients must have a Zubrod performance status of 0 to 2
    • Patients with adequate bone marrow function
    • Patients with adequate renal function
    • Patients with adequate hepatic function
    • Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
    • Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
    • Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

  1. Disease-Specific Exclusions

    • Superior sulcus tumors
    • Atelectasis or obstructive pneumonitis of the entire lung
    • Malignant pleural effusion

  2. General Medical Exclusions

    • Surgical candidates
    • Patients who are pregnant at the time of diagnosis
    • Serious concomitant systemic disorders incompatible with the study
    • Inability to comply with study and/or follow-up procedures
    • Life expectancy of less than 12 weeks
    • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
    • Patients with septicemia or severe infection.
    • Patients who have circumstances that will not permit completion of this study or the required follow-up
    • Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response using RECIST criteria
Time Frame: 12/31/2014
12/31/2014

Secondary Outcome Measures

Outcome Measure
Time Frame
Locoregional control
Time Frame: 12/31/2014
12/31/2014
Distant failure
Time Frame: 12/31/2014
12/31/2014
Progression free survival
Time Frame: 12/31/2014
12/31/2014

Collaborators and Investigators

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

Sponsor

Leo W. Jenkins Cancer Center

Investigators

  • Principal Investigator: Paul Walker, MD, Brody School of Medicine at East Carolina University

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.

General Publications

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

February 1, 2007

Primary Completion (Actual)

August 22, 2017

Study Completion (Actual)

August 22, 2017

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LJCC 07-01

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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