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van CCT (UK)


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van CCT (UK)


A phase II study of erlotinib and bevacizumab in patients with locally advanced and/or metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who have not received prior chemotherapy.


- candidate number1874
- NTR NumberNTR528
- ISRCTNISRCTN78329606
- Date ISRCTN created20-feb-2007
- date ISRCTN requested13-jan-2006
- Date Registered NTR1-dec-2005
- Secondary IDsN/A 
- Public TitleA phase II study of erlotinib and bevacizumab in patients with locally advanced and/or metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who have not received prior chemotherapy.
- Scientific TitleA phase II study of erlotinib and bevacizumab in patients with locally advanced and/or metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who have not received prior chemotherapy.
- ACRONYMPhase II study of erlotinib and bevacizumab as first line treatment in patients with advanced NSCLC.
- hypothesisTumor response from erlotinib and bevacizumab as first line treatment in advanced NSCLC will result in “non-progressive disease” within 6 weeks in more than 50% of patients.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. 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 hemoptysis in the 28 days prior to randomization;
2. 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;
3. Measurable disease as defined by RECIST criteria;
4. Age 18 or greater;
5. ECOG performance status of 0-2;
6. Life expectancy of at least 12 weeks;
7. At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC =< 1) from acute toxicities of any previous therapy;
8. Neutrophils >= 1.5 x 109/L and platelets > 100 x 109/L;
9. Serum bilirubin =< 1.5 upper limit of normal (ULN). ASAT/ALAT =< 2.5 x ULN (in case of livermetastases =< 5 x ULN), Alkaline phosphatase =< 2.5 x ULN;
10. Serum creatinine =< 1.5 ULN or creatinine clearance >= 60 ml/min;
11. Urine dipstick for proteinuria < 2+. Patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate =< 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.
- Exclusion criteria1. 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 0 (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 CNS metastases or spinal cord compression with evidence of stable disease for at least 2 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 hemorrhagic disorders;
10. Current or recent (within 10 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 IV catheters;
11. History of >= grade 2 hemoptysis (symptomatic and medical intervention indicated);
12. Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration;
13. Nursing mothers.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2008
- Target number of participants46
- InterventionsAll patients will receive:
1. Erlotinib 150 mg/day orally;
2. Bevacizumab 15 mg/kg every 3 weeks as a 90 minutes infusion.
- Primary outcomeEfficacy of erlotinib and bevacizumab in first line treatment of NSCLC as determined by the rate of no progression at 6 weeks.
- Secondary outcomeEfficacy 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.J.M. Groen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.J.M. Groen
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsN/A
- Brief summaryAn open label, multicenter, phase II study of erlotinib and bevacizumab in patients with locally advanced and/or metastatic NSCLC who have not received prior chemotherapy. Primary objective: Efficacy of combination of erlotinib and bevacizumab as determined by the rate of no progression at 6 weeks. Secundary objectives: Efficacy of erlotinib and bevacizumab as determined by -the objective response rate and disease control rate -duration of response -time to disease progression or death -survival -safety of erlotinib and bevacizumab Number of patients: 46 patients Study population: 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 hemoptysis in the 28 days prior to randomization.
- Main changes (audit trail)
- RECORD1-dec-2005 - 15-dec-2010


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