A Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Susanne Arnold1 site in 1 country10 target enrollmentNovember 2004

ConditionsNon-Small Cell Lung Cancer

InterventionsDocetaxel Radiation

DrugsDocetaxel

Overview

Phase: Phase 1
Intervention: Docetaxel
Conditions: Non-Small Cell Lung Cancer
Sponsor: Susanne Arnold
Enrollment: 10
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

January 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Susanne Arnold

Responsible Party

Sponsor Investigator

Principal Investigator

Susanne Arnold

Principal Investigator

University of Kentucky

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.

Exclusion Criteria

•No prior single-agent, weekly Docetaxel chemotherapy.
•Peripheral neuropathy ≥ Grade
•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.

Arms & Interventions

1

Intervention: Docetaxel

1

Intervention: Radiation

Outcomes

Primary Outcomes

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.

Time Frame: continuously through treatment

Secondary Outcomes

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)