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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

continuously through treatment

Safety Issue:

Yes

Principal Investigator

Susanne Arnold, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky

Authority:

United States: Institutional Review Board

Study ID:

04-LUN-69-UKY

NCT ID:

NCT00378404

Start Date:

November 2004

Completion Date:

November 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Non-Small Cell Lung Cancer
  • Non-Small Cell
  • Lung Cancer
  • Docetaxel
  • Radiation
  • Metastatic
  • Recurrent
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of KentuckyLexington, Kentucky  40536-0098