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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Radiation: Radiation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	continuously through treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Susanne Arnold
• Collaborators: Kentucky Lung Cancer Research Program
• Investigators: Principal Investigator: Susanne Arnold, MD, University of Kentucky

Publications and helpful links

Helpful Links

• University of Kentucky Markey Cancer Center Clinical Trials Listing

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 18, 2006
• First Submitted That Met QC Criteria: September 19, 2006
• First Posted (Estimate): September 20, 2006

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Docetaxel; Lung Cancer; NSCLC; Non-Small Cell Lung Cancer; Metastatic; Recurrent; Radiation; Non-Small Cell
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 04-LUN-69-UKY