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

Sponsored by:	Simmons Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00547105

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 II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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)

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

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

Locations

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas Southwestern Medical Center at Dallas ( Regulatory Affairs Associate )
Study ID Numbers:	CDR0000571634, SCCC-042007-003, SCCC-0609131
Study First Received:	October 19, 2007
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00547105 History of Changes
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

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009