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AzTrials

Non-Small-Cell Lung CarcinomaPhase 2MIMEBNCT01047059

Molecular Imaging With Erlotinib and Bevacizumab

A Phase 2 study testing Erlotinib, Bevacizumab, Fluoro-D-glucose and Fluoro-L-thymidine in people with Non-Small-Cell Lung Carcinoma, run by University of Cologne at 1 site in Germany.

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

The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging procedures will be performed at baseline, after one week of therapy and after the six weeks of treatment. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
Erlotinib, Bevacizumab, Fluoro-D-glucose and Fluoro-L-thymidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
Jan 2010to May 2016
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically or cytologically proven non-squamos NSCLC stage IIIB with pleural effusion or stage IV
  • ≥ 18 years of age
  • Performance status ECOG 0-2
  • Estimated life expectancy of at least 12 weeks
  • Subjects with at least one measurable or nonmeasurable (CT or MRI) lesion according to RECIST
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
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  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500 /mm3
  • Platelet count ≥ 100 000/μL
  • Total bilirubin ≤ 2 x ULN
  • ALT, AST and alkaline phosphatase (AP) ≤ 2,5 x ULN
  • PT-INR/PTT < 1.5 x ULN
  • Creatinine clearance (CrCl) ≥ 60 ml/min calculated by either Cockcroft-Gault or by 24 hours urine collection
  • Written informed consent (after adequate explanation of the trial) to participate in the trial and to adhere to trial procedures, as well as consenting to data protection procedures
  • No clinical or radiological sign of interstitial lung disease, no interstitial lung disease in the past
  • Patients must be able to take oral medication
  • In case of female patients with childbearing potential:
  • negative serum or urine HCG in women with childbearing potential
  • effective method of contraception (Pearl-Index not greater than 1%)
  • at least 12 months after last menstruation

Who cannot join

  • Patient has received prior chemotherapeutic regimens for advanced disease. Prior chemotherapy given as neoadjuvant or adjuvant therapy for early stage disease, completed at least 12 months prior to diagnosis of advanced stage disease, will not be considered as exclusion criterion.
  • Patient has received prior EGFR-targeted therapy
  • Squamous-cell carcinoma (SCC) histology, SCLC histology or mixed histology
  • Evidence of tumor invading or abutting major blood vessels
  • Patient has signs or symptoms of acute infection requiring systemic therapy (acute or within the last 14 days)
  • Uncontrolled diabetes mellitus with HbA1c > 7,5% or elevated blood glucose levels levels of > 200 mg/dL
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  • History of uncontrolled heart disease (congestive heart failure > NYHA class 2; active Coronary Arterial Disease (CAD), (MI more than 6 months prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (except, when controlled by beta blockers or digoxin) and/or uncontrolled hypertension (> 150/100 mmHg)
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of erlotinib and (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection, total parenteral nutrition with lipids)
  • History of HIV infection or previously sero-positive for the virus
  • History of Hepatitis B or/and C or previously sero-positive for the Hepatitis B or/and C virus
  • Patients with seizure disorder requiring CYP3A4-inducing anti-epileptics
  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis
  • History of thrombotic disorders within the last 6 months prior to enrolment
  • Fine needle biopsy or open biopsy within 1 week prior inclusion
  • Clinically symptomatic leptomeningeal or brain metastases (patients with clinically stable brain metastases may be enrolled)
  • Impaired wound healing, non-healing wounds, ulcers, fractures or any condition that provokes uncontrolled bleeding
  • Preexisting neuropathia ≥ grade 2 • History of grade ≥2 hemoptysis (bright red blood of at least 2.5 ml)
  • Patients undergoing renal dialysis
  • Past or current history of cancer other than the entry diagnosis 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.
  • Any person being in an institution on assignment of the respective authority
  • Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  • Concomitant or intented anticoagulation therapy
  • Planned surgical or dental invasive intervention (e.g. tooth extraction, planned surgeries) during the course of the study
  • Any serious medical condition with organ impairment
  • Hypersensitivity to bevacizumab or erlotinib or any of their ingredients
  • Major surgery or significant traumatic injury within the last 4 weeks before inclusion
  • Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-life's, whatever is of longer duration, prior study start
  • Pregnancy, breast feeding
  • Claustrophobia
  • Known allergic reaction to Gadolinium
  • Heart pacemaker
  • Ferromagnetic and electronic implants in special locations (e. g. cerebral)
  • Cochlea implants
  • known allergic reaction to non-ionic iodinated computed tomography contrast agents
  • known hyperthyroidism

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Center for Integrated Oncology (CIO), University Hospital Cologne

    Cologne, North Rhine-Westphalia, 50924

Other trials in Germany

About this study

Official title: Clinical Pilot to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients With Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) Treated With Erlotinib and Bevacizumab and to Associate Imaging Findings With Molecular Markers

The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging procedures will be performed at baseline, after one week of therapy and after the six weeks of treatment.

The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed recently in a phase II trial. Early differentiation of patients profiting and of patients not profiting from this therapy is of major relevance for further improving this targeted therapy approach and to develop more effective, personalized treatment strategies. We aim at this early identification by the combination of molecular and functional imaging tools (FDG-, FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS mutational status and high throughput mutational profiling in tumor tissue, angiogenesis-associated biomarkers and expression profiling in peripheral blood) and pharmokokinetic analyses. From the combined analyses of these tools we expect a better understanding of the host-drug interaction as a precondition for further improvement of erlotinib-bevacizumab combination therapy in NSCLC

Being tested
Erlotinib, Bevacizumab, Fluoro-D-glucose, Fluoro-L-thymidine, Gadolinium-DPTA
Keywords
NSCLC, Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • Erlotinib, BevacizumabDrug

    Also called Tarceva, Avastin

    Erlotinib 150mg/d d1-d43 p.o. Bevacizumab 15mg/kg b. w. d1, d22, d43 i.v.

  • Fluoro-D-glucoseDrug

    Also called FDG-PET

    Tracer for PET imaging

  • Fluoro-L-thymidineDrug

    Also called FLT-PET

    FLT-PET tracer for imaging

  • Gadolinium-DPTADrug

    Also called Gd-DPTA, Magnevist

    Contrast agent for DCE-MRI imaging

Study groups in NCT01047059
Study groupRoleWhat they receive
Trial InterventionExperimental150mg Erlotinib daily, 15mg/kg b.w. Bevacizumab on d1, d22, d43 as medication FDG-PET, FLT-PET and DCE-MRI as diagnostical tools
Receives: Drug: Erlotinib, Bevacizumab; Drug: Fluoro-D-glucose; Drug: Fluoro-L-thymidine; Drug: Gadolinium-DPTA

What is being measured

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

  1. To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression and progression-free survival after 6 weeks of therapy

    Measured: 24 months

Secondary outcomes (1)

  1. Correlation of mutational profiling with imaging characteristics Prognostic accuracy of imaging Pharmacokinetic analysis Reliability of DCE-MRI Correlation of peripheral biomarkers with clinical outcome, mutational profiling, imaging characteristics

    Measured: 24 months

Timeline

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

  1. First posted12 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionOct 2012
  4. Study completionMay 2016

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01047059
Sponsor's protocol ID
MIMEB
Other IDs
2009-012607-26, 2009
Acronym
MIMEB
Status last verified
May 2016
First submitted
10 Jan 2010
Last updated
20 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib, Bevacizumab, Fluoro-D-glucose and Fluoro-L-thymidine in people with Non-Small-Cell Lung Carcinoma, run by University of Cologne at 1 site in Germany.

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 20 inclusion and 37 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression and progression-free survival after 6 weeks of therapy (time frame: 24 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 NCT01047059.

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 20 May 2016.

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