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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Kentucky Lung Cancer Research Program
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00378404
First received: September 18, 2006
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: Docetaxel
Radiation: Radiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: continuously throughout treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2004
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378404

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

Additional Information:
No publications provided

Responsible Party: Susanne Arnold, MD, Associate Professor of Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT00378404     History of Changes
Other Study ID Numbers: 04-LUN-69-UKY
Study First Received: September 18, 2006
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014