Contact information
Type
Scientific
Primary contact
Prof H J M Groen
ORCID ID
Contact details
University Medical Centre Groningen (UMCG)
Department of Pulmonary Disease
PO Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 6161
h.j.m.groen@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Tumour response from erlotinib and bevacizumab as first line treatment in advanced Non-Small Cell Lung Cancer (NSCLC) will result in non-progressive disease within six weeks in more than 50% of patients.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
An open label, multicentre, phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Non Small Cell Lung Cancer (NSCLC)
Intervention
All patients will receive:
1. Erlotinib 150 mg/day orally
2. Bevacizumab 15 mg/kg every three weeks as a 90 minutes infusion
Intervention type
Drug
Phase
Phase II
Drug names
Erlotinib and bevacizumab
Primary outcome measure
Efficacy of erlotinib and bevacizumab in first line treatment of NSCLC as determined by the rate of no progression at six weeks.
Secondary outcome measures
Efficacy of erlotinib and bevacizumab as determined by:
1. The objective response rate
2. Duration of response
3. Time to disease progression or death
4. Survival
5. Safety of erlotinib and bevacizumab
Overall trial start date
01/01/2006
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cytologically or histologically advanced non-squamous NSCLC. Patients with squamous cell histology are eligible only if their intrathoracic disease has been completely resected, they have no current evidence of intrathoracic disease (with the exception of isolated pleural effusion), and they have not had haemoptysis in the 28 days prior to randomisation
2. No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the Human Epidermal growth factor Receptor (HER) axis (e.g. Epidermal Growth Factor Receptor Tyrosine Kinase [EGFR TK] inhibitors, Herceptin). Prior surgery and/or localised irradiation is permitted provided that the irradiated lesion is not the only measurable lesion
3. Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
4. Age 18 or greater
5. Eastern Cooperative Oncology Group (ECOG) performance status of zero to two
6. Life expectancy of at least 12 weeks
7. At least four weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than four weeks may also be considered for the study. Patients must have recovered (Common Toxicity Criteria [CTC] less than or equal to one) from acute toxicities of any previous therapy
8. Neutrophils more than or equal to 1.5 x 10^9/L and platelets more than 100 x 10^9/L
9. Serum bilirubin less than or equal to 1.5 x Upper Limit of Normal (ULN). Aspartate aminotransferase (ASAT)/Alanine aminotransferase (ALAT) less than or equal to 2.5 x ULN (in case of liver metastases less than or equal to 5 x ULN), Alkaline phosphatase less than or equal to 2.5 x ULN
10. Serum creatinine less than or equal to 1.5 x ULN or creatinine clearance more than or equal to 60 ml/min
11. Urine dipstick for proteinuria less than 2+. Patients discovered to have more than or equal to 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate less than or equal to 1 g of protein/24hr
12. Normal serum calcium
13. Able to comply with study and follow-up procedures
14. Able to take oral medication
15. For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before registration starting therapy
16. Patients with reproductive potential must use effective contraception
17. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease)
2. Evidence of tumour invading major blood vessels
3. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day zero (patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study
4. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
5. Serious non-healing wound or ulcer
6. Evidence of bleeding diathesis or coagulopathy. Presence of a cavitary lesion or evidence of tumor invading or abutting major blood vessels
7. Brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been treated with surgery and/or radiation; previously diagnosed and treated Central Nervous System (CNS) metastases or spinal cord compression with evidence of stable disease for at least two months is permitted
8. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease
9. History of haemorrhagic disorders
10. Current or recent (within ten days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling Intravenous (IV) catheters
11. History of more than or equal to grade two haemoptysis (symptomatic and medical intervention indicated)
12. Ongoing treatment with aspirin (more than 325 mg/day) or other medications known to predispose to gastrointestinal ulceration
13. Nursing mothers
Recruitment start date
01/01/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
PO Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Roche Nederland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list