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

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00449657

Run by

Leo W. Jenkins Cancer Center

People needed

24

Starts

2007-02-01

Expected to finish

2017-08-22

Last updated by the study team

2018-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• Disease-Specific Exclusions
• Superior sulcus tumors
• Atelectasis or obstructive pneumonitis of the entire lung
• Malignant pleural effusion
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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