Status:
TERMINATED
Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC
Lead Sponsor:
Susanne Arnold
Collaborating Sponsors:
Kentucky Lung Cancer Research Program
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00378404
Start Date
November 1 2004
End Date
January 1 2010
Last Update
June 8 2015
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536