Status:
TERMINATED
Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC
Lead Sponsor:
Leo W. Jenkins Cancer Center
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-s...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00449657
Start Date
February 1 2007
End Date
August 22 2017
Last Update
March 14 2018
Active Locations (1)
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1
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834