Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00531076 |
Recruitment Status
:
Terminated
(Study terminated due to toxicity)
First Posted
: September 18, 2007
Last Update Posted
: April 5, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Toxicity | Biological: bevacizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

-
Biological: bevacizumab
Intravenous bevacizumab at 7.5mg/kg and 15mg/kg concurrently with thoracic radiotherapy in sequential cohorts.
In the final dose level, bevacizumab 15mg/kg concurrent with radiation will be followed by maintenance bevacizumab 15mg/kg up to a maximum of 6 cycles
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531076
Netherlands | |
VU University Medical Center | |
Amsterdam, Netherlands, 1007 MB |
Principal Investigator: | Suresh Senan, MD, PhD | VU University Medical Center | |
Principal Investigator: | Egbert F Smit, MD, PhD | VU University Medical Center |
Responsible Party: | Professor Suresh Senan, VU Medical Center |
ClinicalTrials.gov Identifier: | NCT00531076 History of Changes |
Other Study ID Numbers: |
VUMC 2006/194 NL13724.029.06 EudraCTnumber 2006-003149-17 |
First Posted: | September 18, 2007 Key Record Dates |
Last Update Posted: | April 5, 2011 |
Last Verified: | January 2011 |
Keywords provided by VU University Medical Center:
bevacizumab thoracic radiotherapy locally-advanced non-small cell lung cancer |
Additional relevant MeSH terms:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |