Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC
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.
Checked against the public recordLast updated Jun 8, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Susanne Arnold
- Interventions being studied
- Drug: Docetaxel; Radiation: Radiation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of KentuckyLexington, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 8, 2015. Always confirm current availability with the study team.