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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedOver 18OtherLJCC 07-01
NCT00449657

Trial Description

Summary

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

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Leo W. Jenkins Cancer Center at ECU Medical School

Paul Walker, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00449657
ClinicalTrials.gov processed this data on October 23, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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