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Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00547105
Recruitment Status : Completed
First Posted : October 22, 2007
Results First Posted : April 23, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Erlotinib Radiation: SBRT Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the effect of erlotinib and stereotactic body radiotherapy on 6-month progression-free survival of patients with locally advanced or metastatic non-small cell lung cancer.

Secondary

  • To describe the actuarial rate of in-field local control and out-of-field disease progression in patients treated with this regimen.
  • To evaluate the safety of this regimen in these patients.
  • To evaluate overall survival of patients treated with this regimen.
  • To evaluate the duration of erlotinib usage and time to initiation of third-line systemic therapy (chemotherapy or biologic agent) in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. Beginning 1-4 weeks after the initiation of erlotinib hydrochloride, patients undergo stereotactic body radiotherapy.

After completion of study treatment, patients are followed every 3 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a single arm phase II pilot trial. Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib. Maintenance erlotinib will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erlotinib (Tarceva®) in Combination With Stereotactic Body Radiation Therapy (SBRT) for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : June 25, 2007
Actual Primary Completion Date : July 6, 2016
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: erlotinib in combination with SBRT
Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib
Drug: Erlotinib
Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Other Name: Tarceva

Radiation: SBRT
SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Other Name: stereotactic body radiation therapy




Primary Outcome Measures :
  1. 6 Month Progression-Free Survival [ Time Frame: 6 months ]

    For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.



Secondary Outcome Measures :
  1. In-field Local Control [ Time Frame: 9 months ]
    In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.

  2. Number of Participants Without Serious Adverse Events Related to Radiation [ Time Frame: 3 years ]
    Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events

  3. Overall Survival [ Time Frame: up to 5 years ]
    evaluate overall survival after SBRT in combination with erlotinib

  4. Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy [ Time Frame: 3 years ]
    To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)

  5. Out-of-field Disease Progression [ Time Frame: 9 months ]
    Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months

  6. Progression-free Survival [ Time Frame: up to 5 years ]

    For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.




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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  1. Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
  2. Patients must have had failure of at least one prior chemotherapy regimen.
  3. Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
  4. Age ≥ 18 years
  5. Patients must have measurable disease at baseline.
  6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.

    1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
    2. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
    3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
    4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.
  7. Patients must have a KPS >60
  8. AST, ALT & Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
  9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
  10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
  11. Females of childbearing potential should have a negative pregnancy test.
  12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
  13. Patients must provide verbal and written informed consent to participate in the study.
  14. Total bilirubin: within normal institutional limits

Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be enrolled in this study.

  1. Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
  2. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
  3. Patients with serious, uncontrolled, concurrent infection(s).
  4. Significant weight loss (>10%) in the prior 3 months.
  5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
  6. Patients with cutaneous metastasis of NSCLC.
  7. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
  8. Patients with more than 6 discrete extra-cranial lesions.
  9. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  10. Unwillingness to participate or inability to comply with the protocol for the duration of the study.
  11. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.
  12. Patients who have had prior EGFR inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547105


Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00547105     History of Changes
Other Study ID Numbers: SCCC-0609131
SCCC-042007-003 ( Other Identifier: UT Southwestern )
CDR0000571634 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 22, 2007    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: May 22, 2018
Last Verified: April 2018

Keywords provided by University of Texas Southwestern Medical Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action