Clinical trial NCT00378404: Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Non-Small Cell Lung Cancer
Non-Small Cell
Lung Cancer
Docetaxel
Radiation
Metastatic
Recurrent
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Kentucky Lung Cancer Research Program
First posted: 2006-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 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.
timeFrame: continuously through treatment
Secondary outcomes:
measure: Toxicity
timeFrame: continuously throughout treatment
measure: 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.
timeFrame: week 1
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Susanne Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: