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Non-Small Cell Lung CancerPhase 2NCT00722969

Erlotinib and Sorafenib in Chemonaive Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

A Phase 2 study testing sorafenib + erlotinib in people with Non-Small Cell Lung Cancer, run by Universitair Ziekenhuis Brussel at 4 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib 400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this combination treatment. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
sorafenib + erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesNetherlands
Study dates
Nov 2007to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically/cytologically advanced NSCLC stage IIIB or IV
  • No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized irradiation is permitted provided that the irradiated lesion is not the only measurable lesion.
  • Age > 18 years.
  • ECOG Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks.
  • Subjects with at least one uni-dimensional(for RECIST) measurable lesion. Lesions must be measured by CT-scan.
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  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count > 100,000/μl
  • Total bilirubin < 1.5 times the upper limit of normal
  • ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • Alkaline phosphatase < 4 x ULN
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with low molecular weight heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
  • Serum creatinine < 1.5 x upper limit of normal.
  • Written informed consent.

Who cannot join

  • Excluded medical conditions:
  • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
  • History of HIV infection or chronic hepatitis B or C.
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors (unless the patient is > 1 months from definitive radiotherapy and off steroids):
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
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  • History of organ allograft.
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry.
  • Excluded therapies and medications, previous and concomitant:
  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 3 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Prior exposure to the study drugs.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • Patients unable to swallow oral medications.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • VU university medical center

    Amsterdam, 1007 MB

  • Netherlands Cancer Institute

    Amsterdam

  • University Medical Center Groningen

    Groningen

  • University Hospital Maastricht

    Maastricht

Other trials in Netherlands

About this study

Official title: A Phase II Study of Erlotinib and Sorafenib in Patients With Locally Advanced and/or Metastatic (Stage IIIb or IV) Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib 400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this combination treatment. Additional exploratory study objectives are correlation of biomarkers and imaging modalities potentially predictive for response and (progression free) survival.

Being tested
sorafenib + erlotinib
Keywords
non-small cell lung cancer, erlotinib, sorafenib
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.

  • sorafenib + erlotinibDrug

    Also called nexavar, tarceva

    sorafenib 400mg b.i.d oral Erlotinib 150 mg o.i.d oral

Study groups in NCT00722969
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: sorafenib + erlotinib

What is being measured

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

  1. Rate of non-progression at 6 weeks

    Measured: 6 weeks

Secondary outcomes (6)

  1. Best overall response rate

    Measured: end of study

  2. Duration of response

    Measured: End of study

  3. Survival

    Measured: End of study

  4. Toxicity

    Measured: Week 1, week 3, week 6, week 9, week 12 then every 6 weeks

  5. Prediction of early response and effects on tumor vascularisation by PET and perfusion CT scans

    Measured: Baseline, week 3 and week 6

  6. Biomarkers for response (Proteomics, circulating cells, mutational analysis)

    Measured: Baseline, week 1, week 3 and week 6

Timeline

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

  1. First posted28 Jul 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionNov 2008 (estimated)
  4. Study completionApr 2009 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722969
Sponsor's protocol ID
07/203
Other IDs
EudraCT: 2007-004625-14
Status last verified
Mar 2009
First submitted
24 Jul 2008
Last updated
3 Mar 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib + erlotinib in people with Non-Small Cell Lung Cancer, run by Universitair Ziekenhuis Brussel at 4 sites in Netherlands.

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 16 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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?

Results are not available in the source record.

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?

Rate of non-progression at 6 weeks (time frame: 6 weeks). 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 NCT00722969.

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 3 Mar 2009.

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