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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival

Safety Issue:

No

Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

Unspecified

Study ID:

CDR0000571634

NCT ID:

NCT00547105

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045