Erlotinib and Stereotactic Body Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Non-Small Call Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Primary Purpose: Treatment
Intervention
Name: erlotinib hydrochloride Type: Drug
Name: stereotactic body radiation therapy Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Colorado Cancer Center - 720-848-0650
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a - 866-460-4673; 214-648-7097
Start Date
June 2007
Sponsors
Simmons Cancer Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page