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

NCT00547105 | Completed Phase 2 Results

• 3 other identifiers: SCCC-0609131SCCC-042007-003CDR0000571634
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

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

Outcome Measures

Primary Outcomes (1)

• 6 Month Progression-Free Survival

  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.

  6 months

Secondary Outcomes (6)

• In-field Local Control

  9 months

• Number of Participants Without Serious Adverse Events Related to Radiation

  3 years

• Overall Survival

  up to 5 years

• Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy

  3 years

• Out-of-field Disease Progression

  9 months

Study Arms (1)

erlotinib in combination with SBRT

EXPERIMENTAL

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; Radiation: SBRT

Interventions

Erlotinib DRUG

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.

Also known as: Tarceva

erlotinib in combination with SBRT

SBRT RADIATION

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

Also known as: stereotactic body radiation therapy

erlotinib in combination with SBRT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with cutaneous metastasis of NSCLC.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
• Patients with more than 6 discrete extra-cranial lesions.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.
• Patients who have had prior EGFR inhibitors.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Director of Clinical Trial
• Organization: UT Southwestern Medical Center

ClinicalTrials@utsouthwestern.edu

Study Officials

• Robert D. Timmerman, MD

  Simmons Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: June 25, 2007
• Primary Completion: July 6, 2016
• Study Completion: July 6, 2017
• Last Updated: August 21, 2020
• Results First Posted: April 23, 2018

Record last verified: 2018-04

Locations

US (2)