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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

Phase 2
18 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma

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Trial Information

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

Inclusion Criteria:

- 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

- 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 ≤ 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

- 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

Exclusion Criteria:

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Jürgen Wolf, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lung Cancer Group Cologne (LCGC)


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2010

Completion Date:

June 2012

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms