NCT00378404

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2004

Typical duration for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

4.6 years

First QC Date

September 18, 2006

Last Update Submit

June 3, 2015

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLCNon-Small Cell Lung CancerNon-Small CellLung CancerDocetaxelRadiationMetastaticRecurrent

Outcome Measures

Primary Outcomes (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.

    continuously through treatment

Secondary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: DocetaxelRadiation: Radiation

Interventions

DocetaxelDRUG

30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles

1
RadiationRADIATION

50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasm MetastasisRecurrence

Interventions

DocetaxelRadiation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPhysical Phenomena

Study Officials

  • Susanne Arnold, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 20, 2006

Study Start

November 1, 2004

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)