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Non-Small Cell Lung CancerPhase 2NCT00609804

Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

A Phase 2 study testing Sorafenib and Erlotinib in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Sorafenib and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
16 sitesUnited States
Study dates
Mar 2008to Nov 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed stage IIIB/IV or relapsed non-small cell lung carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Patients with mixed tumors with small-cell elements are ineligible.
  • Patients with no more than 2 prior lines of therapy, with the latest of those therapies being single-agent erlotinib.
  • Evidence of progressive disease on erlotinib as assessed by the treating physician. Erlotinib must be the last treatment for NSCLC prior to enrollment into this study. Patients may be on erlotinib until enrollment. If erlotinib has already been stopped, the period of time off Erlotinib cannot exceed 14 days prior to study enrollment.
  • Patients must have experienced a clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) from prior therapy with erlotinib for a period of 8 weeks.
  • Patient must have one measurable lesion measuring at least 10 mm in the longest diameter (LD) by spiral computed tomography (CT), or 20 mm with conventional techniques according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Recovery from any toxic effects of erlotinib to ≤ grade 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
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  • Completion of palliative radiation therapy prior to the start of study treatment. Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed following the completion of radiation therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Absolute neutrophil count (ANC) >=1,500 and platelets >=75,000 (within 7 days prior to initial study treatment).
  • Hemoglobin >=9 g/dL (within 7 days prior to initial treatment).
  • International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution if not on anticoagulation therapy. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate with the therapeutic range established prior to study treatment initiation.
  • Serum creatinine <=1.5 x institutional upper limit of normal (ULN) within 7 days prior to initial study treatment. If the absolute value is greater than 2mg/dL, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >=45 mL/min to be eligible.
  • Bilirubin <=1.5 x the ULN; transaminases <=3 x institutional ULN, except in known hepatic metastasis, wherein these may be >=5 x institutional ULN.
  • Patients must be able to understand the nature of this study, give written informed consent, and comply with study requirements.
  • Agreement of male patients (with partners of childbearing potential) and female patients of childbearing potential to use effective contraception to prevent pregnancy during treatment and for a minimum of 90 days thereafter. Additionally, women should not breastfeed during this time.

Who cannot join

  • Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) >=3 years.
  • Pregnancy or lactation. All females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment.
  • Prior epithelial growth factor receptor (EGFR) inhibitors, with the exception of erlotinib, are not allowed. This includes both tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Prior vascular endothelial growth factor (VEGF) inhibitors, with the exception of bevacizumab, are not allowed.
  • Significant cardiac disease within 90 days of starting study treatment including:
  • superior vena cava syndrome
  • new onset angina
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  • congestive heart failure (CHF) > Class 2 per New York Heart Association (NYHA) classification
  • arrhythmia
  • valvular heart disease.
  • Myocardial infarction within 6 months prior to initiation of study treatment
  • Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution.
  • Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mm Hg and/or diastolic BP >100 mm Hg on antihypertensive medications).
  • Unstable angina (anginal symptoms at rest).
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
  • A serious active infection (> grade 2) at the time of treatment
  • A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Untreated brain metastases. Patients who have treated metastases >=4 weeks out (with surgery and/or radiation therapy) and no evidence of central nervous system (CNS) progression are eligible.
  • Treatment with a non-approved or investigational drug within 28 days of initial study treatment.
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment or anticipation of need for major surgery during the course of the study.
  • Thrombolic or embolic events such as a stroke and transient ischemic attack (TIA) within the past 6 months.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of initial study treatment.
  • Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of initial study treatment.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
  • Any malabsorption problem.
  • Any condition that impairs the patient's ability to swallow whole pills.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70806

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Associates in Hematology Oncology

    Chattanooga, Tennessee, 37404

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Wellstar Cancer Research

    Marietta, Georgia, 30060

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Being tested
Sorafenib, Erlotinib
Keywords
Non-Small Cell Lung Cancer, Advanced, Erlotinib, Sorafenib, Progressing on erlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called Nexavar

    Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib 150 mg once daily by mouth

Study groups in NCT00609804
Study groupRoleWhat they receive
Sorafenib+ErlotinibExperimentalSorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth
Receives: Drug: Sorafenib; Drug: Erlotinib
SorafenibActive comparatorSorafenib 400 mg twice daily by mouth.
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 18 months

Secondary outcomes (2)

  1. Overall Response Rate

    The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months

  2. Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

    Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMay 2012
  4. Study completionNov 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609804
Sponsor's protocol ID
SCRI LUN 162
Status last verified
Mar 2016
First submitted
24 Jan 2008
Last updated
8 Apr 2016
Data monitoring committee
No

Publications

  • Spigel DR, Rubin MS, Gian VG, Shipley DL, Burris HA 3rd, Kosloff RA, Shih KC, Quinn R, Greco FA, Hainsworth JD. Sorafenib and continued erlotinib or sorafenib alone in patients with advanced non-small cell lung cancer progressing on erlotinib: A randomized phase II study of the Sarah Cannon Research Institute (SCRI). Lung Cancer. 2017 Nov;113:79-84. doi: 10.1016/j.lungcan.2017.09.007. Epub 2017 Sep 18.

    PubMed 29110854

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib and Erlotinib in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 16 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 15 inclusion and 30 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 2 Jun 2015). 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?

Progression-free Survival (PFS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00609804, which also lists 1 linked publication.

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 8 Apr 2016.

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