NCT00543335

Brief Summary

The goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with radiation therapy to people with lung cancer. The ability of both the study drug and radiation to control the disease will also be studied.

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 lung-cancer

Timeline
Completed

Started Jan 2008

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

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.9 years

First QC Date

October 11, 2007

Last Update Submit

November 13, 2018

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung CancerLung CancerNSCLCRadiation TherapySorafenibBAY 43-9006Thoracic Radiation

Outcome Measures

Primary Outcomes (1)

  • Maximal tolerated dose (MTD) of sorafenib concurrent with thoracic radiation for poor prognosis NSCLC (phase I)

    Continual reassessment of safety throughout study and determination of dose-limiting toxicities during and at end of 3 week cycles.

Secondary Outcomes (1)

  • Efficacy of combination assessed by tumor response and local progression failure (phase II)

    6 Months and 12 Months

Study Arms (1)

Sorafenib + Radiation Therapy

EXPERIMENTAL

Sorafenib starting dose 200 mg orally daily + 45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks

Drug: SorafenibProcedure: Radiation Therapy

Interventions

SorafenibDRUG

Starting dose 200 mg PO (by mouth) Daily

Also known as: BAY 43-9006
Sorafenib + Radiation Therapy
Radiation TherapyPROCEDURE

45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks

Also known as: RT, Radiotherapy
Sorafenib + Radiation Therapy

Eligibility Criteria

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

You may qualify if:

  • Pathologically proven previously untreated or systemically treated poor prognosis NSCLC patients for whom palliative thoracic irradiation is the treatment of choice per standard of care.
  • Patients for whom palliative thoracic irradiation therapy to 45 Gy/15 FX is the recommended treatment by their treating radiation oncologist.
  • The primary tumor and/or regional lymphatic metastases must be evaluable radiographically.
  • Age \>/= 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or greater, weight loss \</= 30% or less.
  • No prior radiation to the thorax.
  • Adequate bone marrow, liver and renal function as assessed by the following: \* Hemoglobin \>/= 9.0 g/dl \* Absolute neutrophil count (ANC) \>/=1,000/mm\^3 \*Platelet count \>/ =100,000/mm\^3 \* Total bilirubin \</= 1.5 times ULN or greater \* ALT and AST \</= 2.5 times the ULN (\</= 5 \* ULN for patients with liver involvement) \* Creatinine \</= 1.5 \* ULN
  • Patients with distant metastasis are eligible.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • INR \< 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of M.D. Anderson Cancer Center. The only approved consent form is attached to this protocol.

You may not qualify if:

  • Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Known hemorrhagic brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude hemorrhagic brain metastasis.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Active clinically serious infection \> CTCAE Grade 3.
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Current use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib.
  • Any malabsorption problem.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD . Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

SorafenibRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Zhongxing Liao, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

January 25, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

US(1)