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

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00547105

Run by

University of Texas Southwestern Medical Center

People needed

24

Starts

2007-06-25

Expected to finish

2017-07-06

Last updated by the study team

2020-08-21

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
• Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
• Patients must have had failure of at least one prior chemotherapy regimen.
• Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• 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.
• 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
• 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.
• Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
• Up to 2 contiguous vertebral metastases will be considered a single site of disease.
• Patients must have a KPS >60
• AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
• Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• Females of childbearing potential should have a negative pregnancy test.
• 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.
• Patients must provide verbal and written informed consent to participate in the study.
• 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.
• 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.
• Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
• Patients with serious, uncontrolled, concurrent infection(s).
• Significant weight loss (>10%) in the prior 3 months.
• 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.

Where it is running

• University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States
• Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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