Non-small-cell Lung CancerPhase 2NCT00749567
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
A Phase 2 study testing Erlotinib and Bevacizumab in people with Non-small-cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Erlotinib and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 10 sitesGreece
- Study dates
- Jul 2008to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
- Progression to first-line therapy for advanced/metastatic NSCLC
- Bi-dimensionally measurable disease (not included in radiation field)
- ECOG performance status of 0-2
- Life expectancy of more than 6 months
- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine <1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- Signed informed consent
Who cannot join
- Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
- Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
- Surgery or radiation therapy within the last 14 days from study entry
- Active infection
- History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension
Show all 10Show fewer
- Patients on other experimental treatment protocols
- History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix)
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
401 Military Hospital, Medical Oncology Unit
Athens
Air Forces Military Hospital, Dep of Medical Oncology
Athens
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens
University Hospital of Heraklion
Heraklion, Crete
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus
Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study
The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.
Read the detailed description
A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab, a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to systemic chemotherapy, improved both the response rates and the time to tumor progression in two trials. Early data from phase I/II trials examining the combination of these two biological agents in pre-treated patients with non-squamous NSCLC, showed no major pharmacokinetic interactions and promising clinical activity.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Erlotinib, Bevacizumab
- Keywords
- NSCLC, TKI's, Anti-VEGF
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Erlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity
BevacizumabDrug
Also called Avastin
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Erlotinib/Bevacizumab Receives: Drug: Erlotinib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Objective responses confirmed by CT or MRI (on 3rd and
Secondary outcomes (4)
Progression Free Survival
Measured: 1 year
Overall Survival
Measured: 1 year
Quality of life assessment
Measured: Assessment every two cycles
Toxicity profile
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- Sofia Agelaki, MD, Principal investigator, University Hospital of Crete, Dep of Medical OncologyManolis Kontopodis, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749567
- Sponsor's protocol ID
- CT/08.15
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2008
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study
- ClinicalTrials.gov ID
- NCT00749567
- Acronym / sponsor ID
- CT/08.15
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- NSCLC, TKI's, Anti-VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jul 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.
Detailed description
A randomized, placebo-controlled phase III trial of erlotinib versus placebo, demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Moreover, the addition of bevacizumab, a monoclonal antibody against Vascular Endothelial Growth Factor bevacizumab (VEGF), to systemic chemotherapy, improved both the response rates and the time to tumor progression in two trials. Early data from phase I/II trials examining the combination of these two biological agents in pre-treated patients with non-squamous NSCLC, showed no major pharmacokinetic interactions and promising clinical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Erlotinib, Drug: BevacizumabErlotinib/Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
- Progression to first-line therapy for advanced/metastatic NSCLC
- Bi-dimensionally measurable disease (not included in radiation field)
- ECOG performance status of 0-2
- Life expectancy of more than 6 months
Key exclusion criteria (10 listed)
- Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable)
- Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation.
- Surgery or radiation therapy within the last 14 days from study entry
- Active infection
- History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: TarcevaErlotinib 150mg daily, continuously, until disease progression or the appearance of unacceptable toxicity | Drug | 1 |
| BevacizumabAlso: AvastinBevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression or the appearance of unacceptable toxicity | Drug | 1 |
Primary outcome
Overall response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and
4 secondary outcomes
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Quality of life assessment
Time frame: Assessment every two cycles
Toxicity profile
Time frame: Assessment every two cycles
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Agelaki, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
Manolis Kontopodis, MD principal investigator
University Hospital of Crete
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and Bevacizumab in people with Non-small-cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Objective responses confirmed by CT or MRI (on 3rd and). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.