Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Verified date | June 2015 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | January 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Susanne Arnold | Kentucky Lung Cancer Research Program |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Toxicity | continuously throughout treatment | Yes | |
Secondary | 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 | No |
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