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Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC

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ClinicalTrials.gov Identifier: NCT00378404
Recruitment Status : Terminated (Slow accrual)
First Posted : September 20, 2006
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Docetaxel Radiation: Radiation Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2004
Primary Completion Date : June 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Docetaxel
30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles
Radiation: Radiation
50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Toxicity [ Time Frame: continuously throughout treatment ]
  2. 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. [ Time Frame: week 1 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378404


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Susanne Arnold
Kentucky Lung Cancer Research Program
Investigators
Principal Investigator: Susanne Arnold, MD University of Kentucky
More Information

Responsible Party: Susanne Arnold, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT00378404     History of Changes
Other Study ID Numbers: 04-LUN-69-UKY
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Susanne Arnold, University of Kentucky:
NSCLC
Non-Small Cell Lung Cancer
Non-Small Cell
Lung Cancer
Docetaxel
Radiation
Metastatic
Recurrent

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action