Non Small Cell Lung Cancer
Conditions
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
Interventions
DRUGTaxol (paclitaxel)
paclitaxel 15mg/m2 Q am on Mon/Wed/Fri
PROCEDURERadiotherapy
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
DRUGCarboplatin
Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9
DRUGGemcitabine
Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9
Sponsors
Leo W. Jenkins Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response using RECIST criteria | 12/31/2014 |
Secondary
| Measure | Time frame |
|---|---|
| Locoregional control | 12/31/2014 |
| Distant failure | 12/31/2014 |
| Progression free survival | 12/31/2014 |
Countries
United States
Outcome results
None listed