Lung CancerPhase 2NCT00547105
Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Erlotinib and SBRT in people with Lung Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Erlotinib and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jun 2007to 6 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
- Patients must have had failure of at least one prior chemotherapy regimen.
- Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
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- Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.
- For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
- Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
- Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
- Up to 2 contiguous vertebral metastases will be considered a single site of disease.
- Patients must have a KPS >60
- AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
- Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
- Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
- Females of childbearing potential should have a negative pregnancy test.
- Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
- Patients must provide verbal and written informed consent to participate in the study.
- Total bilirubin: within normal institutional limits
- Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
- Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (>10%) in the prior 3 months.
- Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- Patients with cutaneous metastasis of NSCLC.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- Patients with more than 6 discrete extra-cranial lesions.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.
- Patients who have had prior EGFR inhibitors.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
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)
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.
Read the 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.
- Conditions
- Lung Cancer
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
SBRTRadiation
Also called stereotactic body radiation therapy
SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
| Study group | Role | What they receive |
|---|---|---|
| erlotinib in combination with SBRT | Experimental | Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Receives: Drug: Erlotinib; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression-Free Survival
For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.
Measured: 6 months
Secondary outcomes (6)
In-field Local Control
In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.
Measured: 9 months
Number of Participants Without Serious Adverse Events Related to Radiation
Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events
Measured: 3 years
Overall Survival
evaluate overall survival after SBRT in combination with erlotinib
Measured: up to 5 years
Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy
To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)
Measured: 3 years
Out-of-field Disease Progression
Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months
Measured: 9 months
Progression-free Survival
For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study start25 Jun 2007
- Primary completion6 Jul 2016
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single arm phase II pilot trial. Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib. Maintenance erlotinib will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D. Timmerman, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547105
- Sponsor's protocol ID
- SCCC-0609131
- Other IDs
- SCCC-042007-003, CDR0000571634
- Status last verified
- Apr 2018
- First submitted
- 19 Oct 2007
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00547105
- Acronym / sponsor ID
- SCCC-0609131
- Conditions
- Lung Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 25 Jun 2007 (actual)
- Primary completion
- 6 Jul 2016 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single arm phase II pilot trial. Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib. Maintenance erlotinib will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death.
| Arm | Type | Receives |
|---|---|---|
| erlotinib in combination with SBRT | Experimental | Drug: Erlotinib, Radiation: SBRTPatients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
- Patients must have had failure of at least one prior chemotherapy regimen.
- Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
- Age ≥ 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: TarcevaErlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. | Drug | erlotinib in combination with SBRT |
| SBRTAlso: stereotactic body radiation therapySBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body | Radiation | erlotinib in combination with SBRT |
Primary outcome
6 Month Progression-Free Survival
Time frame: 6 months
For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.
6 secondary outcomes
In-field Local Control
Time frame: 9 months
Number of Participants Without Serious Adverse Events Related to Radiation
Time frame: 3 years
Overall Survival
Time frame: up to 5 years
Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy
Time frame: 3 years
Out-of-field Disease Progression
Time frame: 9 months
Progression-free Survival
Time frame: up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Timmerman, MD study chair
Simmons Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and SBRT in people with Lung Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Month Progression-Free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.