Clinical Trials /

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

NCT00547105

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: SCCC-0609131
  • SECONDARY ID: SCCC-042007-003
  • SECONDARY ID: CDR0000571634
  • NCT ID: NCT00547105

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
ErlotinibTarcevaerlotinib in combination with SBRT

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
erlotinib in combination with SBRTExperimentalPatients 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
  • Erlotinib

Eligibility 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.
      
Maximum Eligible Age:120 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:6 Month Progression-Free Survival
Time Frame:6 months
Safety Issue:
Description: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

Measure:In-field Local Control
Time Frame:9 months
Safety Issue:
Description:In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.
Measure:Number of Participants Without Serious Adverse Events Related to Radiation
Time Frame:3 years
Safety Issue:
Description:Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events
Measure:Overall Survival
Time Frame:up to 5 years
Safety Issue:
Description:evaluate overall survival after SBRT in combination with erlotinib
Measure:Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy
Time Frame:3 years
Safety Issue:
Description:To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)
Measure:Out-of-field Disease Progression
Time Frame:9 months
Safety Issue:
Description:Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months
Measure:Progression-free Survival
Time Frame:up to 5 years
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • 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

Last Updated

April 23, 2018