Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Non-Small Cell Lung Cancer, Non-Small Cell, Lung Cancer, Docetaxel, Radiation, Metastatic, Recurrent
Brief summary
The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.
Interventions
DRUGDocetaxel
30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles
RADIATIONRadiation
50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles
Sponsors
Kentucky Lung Cancer Research Program
Susanne Arnold
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or greater. * Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen. * Patients who have recurred after previous surgery and/or radiation may participate in this trial. * Patients may have had prior neoadjuvant or adjuvant therapy. * Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration. * Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. * Progression after at least one prior platinum-based chemotherapy. * Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration. * ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration. * Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration. * Patients requiring lung radiation must have an FEV1 of \> 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO. * Zubrod Performance Status of 0,1 or 2.
Exclusion criteria
* No prior single-agent, weekly Docetaxel chemotherapy. * Peripheral neuropathy ≥ Grade 1. * Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years. * Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting. | continuously through treatment |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | continuously throughout treatment |
| To investigate in an exploratory manner, the association of p53, p21^waf1/cip1, bcl-xL, bcl-2 and bax markers in pre- and post-treatment biopsies with patient response and toxicity. | week 1 |
Countries
United States
Outcome results
None listed