View Clinical Trial (Medical Research Study)
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)
| City: |
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Aurora |
| State: |
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Colorado |
| Zip Code: |
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80045 |
| Conditions: |
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Lung Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00547105 |
| Primary Contact: |
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Study Chair
Robert D. Timmerman, MD
Simmons Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Aurora, Colorado 80045
United States
Clinical Trials Office - University of Colorado Cancer Center
Phone: 720-848-0650
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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