Erlotinib and Stereotactic Body Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Non-Small Call Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00547105
First received: October 19, 2007
Last updated: June 22, 2010
Last verified: June 2010
  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.


Condition Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of in-field local control and out-of-field disease progression [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of erlotinib use and time to initiation of third-line systemic therapy [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)

    • Locally advanced or metastatic disease
  • Measurable disease
  • Failed at least one prior chemotherapy regimen
  • No more than 6 discrete active extracranial lesions (≤ 3 in the liver and ≤ 3 in the lung) identified by positron emission tomography (PET) and by correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of stereotactic body radiotherapy (SBRT)

    • Residual PET activity is not considered a site of active disease if the CT scan appearance is stable or improved over a period of ≥ 3 months (for patients who received prior radiotherapy to the primary site in the lung)
    • Patients who received prior radiotherapy to the primary site will be ineligible for the study if there is CT scan evidence of disease progression within the past 3 months
    • Patients with unirradiated primary sites are potentially eligible for the study
    • No more than 2 contiguous vertebral metastases will be considered a single site of disease
  • No metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes
  • No cutaneous metastasis of NSCLC
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • AST and ALT ≤ 2 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2 times ULN
  • Alkaline phosphatase ≤ 5 times ULN
  • Granulocyte count ≥ 1,500/mm³
  • Serum creatinine ≤ 1.5 times ULN
  • FEV1 ≥ 1 L (for patients who will be receiving SBRT for lung tumors and who are known or suspected by the treating radiation oncologist to have compromised lung function)
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious, uncontrolled infection(s)
  • No significant weight loss (> 10%) within the past 3 months
  • No other carcinoma within the past 5 years except cured nonmelanoma skin cancer or treated in situ cervical cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior participation in an investigational drug study
  • No prior EGFR inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547105

Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
Sponsors and Collaborators
Simmons Cancer Center
Investigators
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00547105     History of Changes
Other Study ID Numbers: CDR0000571634, SCCC-042007-003, SCCC-0609131
Study First Received: October 19, 2007
Last Updated: June 22, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014