Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Leo W. Jenkins Cancer Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Tumor response using RECIST criteria
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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-small cell lung cancer
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Tumor response using RECIST criteria
Time Frame: 12/31/2014
Secondary Outcomes
- Locoregional control(12/31/2014)
- Distant failure(12/31/2014)
- Progression free survival(12/31/2014)