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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Leo W. Jenkins Cancer Center
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT00449657
First received: March 16, 2007
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Taxol (paclitaxel)
Procedure: Radiotherapy
Drug: Carboplatin
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • Tumor response using RECIST criteria [ Time Frame: 12/31/2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Locoregional control [ Time Frame: 12/31/2014 ] [ Designated as safety issue: No ]
  • Distant failure [ Time Frame: 12/31/2014 ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 12/31/2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Taxol (paclitaxel)
    paclitaxel 15mg/m2 Q am on Mon/Wed/Fri
    Procedure: Radiotherapy

    Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before.

    Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5

    Drug: Carboplatin
    Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9
    Drug: Gemcitabine
    Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449657

Contacts
Contact: Paul Walker, MD 252-744-1888 walkerp@ecu.edu
Contact: Susan Eubanks, RN, OCN 252-744-1015 eubankss@ecu.edu

Locations
United States, North Carolina
Brody School of Medicine at East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Investigators
Principal Investigator: Paul Walker, MD Brody School of Medicine at East Carolina University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT00449657     History of Changes
Other Study ID Numbers: LJCC 07-01
Study First Received: March 16, 2007
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Gemcitabine
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014