- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00531076
Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer
April 4, 2011 updated by: Amsterdam UMC, location VUmc
Phase I Study of Concurrent Bevacizumab (Avastin) With Involved-field Thoracic Radiotherapy for Inoperable Non-squamous Non-small Cell Lung Cancer, Followed by Both Concurrent and Maintenance Bevacizumab
In spite of the use of radiation combined with conventional chemotherapy, the long-term survival prognosis for most patients with locally advanced non-small cell lung cancer is disappointing.
Much effort is currently focussed on exploring new molecular targeted agents that may improve upon survival.
The addition of an agent that targets blood vessel formation in tumors, bevacizumab or Avastin, to conventional chemotherapy has been shown to improve survival in metastatic non-small cell lung cancer.
Data from animal studies have shown that bevacizumab and related agents also increase tumor cure rates when administered both during and after radiotherapy.
This suggests that combined bevacizumab and chemo-radiation may improve survival in local-advanced disease as well.
Before such clinical studies can commence, the safety and normal tissue toxicity profile of bevacizumab with thoracic radiotherapy must first be established.
In this study, escalating doses of bevacizumab will be administered during radiotherapy, followed by maintenance bevacizumab.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Amsterdam, Netherlands, 1007 MB
- VU University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Cytologically or histologically confirmed stages II or III non-squamous NSCLC
- No evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization.
- No prior systemic therapy for NSCLC. Prior surgery and/or extra-thoracic irradiation is permitted.
- Presence of at least one measurable target lesion
- Age 18 or greater.
- WHO performance status of 0 or 1.
- Acceptable pulmonary function as defined by a Fev1 of ≥30% and a DLCO of ≥40% of predicted
- Life expectancy of at least 12 weeks.
Adequate hematological, renal and hepatic functions
- Absolute neutrophil count >2x109/l.
- Platelet count > 100x109/l.
- Total bilirubin < 1.5 x UNL
- ASAT/ALAT < 2 x UNL
- Alkaline phosphatase < 5 x UNL
- Creatinine < 130 μmol/L
- Creatinine clearance > 60 ml/min; measured or calculated
- Urine dipstick for proteinuria < 1+. If urine dipstick is ≥ 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.
- No pre-existing sensory neurotoxicity grade 2 (CTC)
- No active (uncontrolled) infection requiring antibiotics
Exclusion criteria:
- Mixed tumor types with small cell lung cancer or squamous cell carcinoma
- Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
- Serious non-healing wound or ulcer.
- ASAT and ALAT > 1,5 x UNL
- alkaline phosphatase 5 x UNL
- Evidence of bleeding diathesis or coagulopathy.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- Participation in other trial with investigational drug or treatment modality.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the safety and tolerability of 2 dose-levels of bevacizumab administered every 3 weeks with concurrent thoracic radiotherapy to 66 Gy,and also maintenance (15 mg/kg) bevacizumab following completion of thoracic radiotherapy
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlate all observed toxicity with dose-volume histograms of irradiated normal organs and explore surrogate tumor end-points that may correlate with the efficacy of combined treatment with anti-VEGF targeted therapy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Egbert F Smit, MD, PhD, Amsterdam Umc, Location Vumc
- Principal Investigator: Suresh Senan, MD, PhD, Amsterdam Umc, Location Vumc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 17, 2007
First Submitted That Met QC Criteria
September 17, 2007
First Posted (Estimate)
September 18, 2007
Study Record Updates
Last Update Posted (Estimate)
April 5, 2011
Last Update Submitted That Met QC Criteria
April 4, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- VUMC 2006/194
- NL13724.029.06
- EudraCTnumber 2006-003149-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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