Non-small Cell Lung CancerNCT01963351
Bevacizumab in Combination With Chemotherapy in Patients With Advanced or Recurrent Non-squamous NSCLC
An observational study of Non-small Cell Lung Cancer and Unresectable Malignant Neoplasm, run by University of Athens at 1 site in Greece.
Trial summary
This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Unresectable Malignant Neoplasm
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Jan 2014
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Patients with histologically or cytologically documented advanced metastatic (patients who are not candidates for radiotherapy, i.e. supraclavicular lymph node metastases or Stage IIIb with malignant pleural or pericardial effusion or Stage IV) or recurrent non-squamous non-small cell lung cancer.
Who may be able to join
- 1. Written informed consent 2. Age ≥18 years 3. Able to comply with the protocol 4. Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2 6. Life expectancy ≥12 weeks 7. Adequate haematological function:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
- Platelet count ≥100 x 109/L AND
- Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level) 8. Adequate liver function:
- Total bilirubin <1.5 x upper limit of normal (ULN) AND
- Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases 9. Adequate renal function: calculated creatinine clearance ≥50 mL/min AND
- Urine dipstick for proteinuria <2+. 10. INR ≤1.5 and partial prothrombin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to enrolment 11. If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study
Who cannot join
- Mixed, predominant squamous component
- History of haemoptysis, in the 3 months prior to enrolment
- Evidence of tumour invading major blood vessels
- Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
- Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy f is allowed
Show all 17Show fewer
- Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325mg/day)
- Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Uncontrolled hypertension
- Clinically significant (i.e. active) cardiovascular disease
- Non-healing wound, active peptic ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, means of contraception Men who do not agree to use effective contraception during the study
- 18. Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies 19. Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications 20. Patients diagnosed with a tracheo-esophageal fistula 21. Prior chemotherapy or treatment with another systemic anti-cancer agent 22. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent 23. History of thrombotic disorders within the last 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
Read the detailed description
It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.
- Keywords
- NSCLC, Non-squamous
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced and metastatic nsclc | non squamous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events during 24 months of follow-up
Measured: 24 months
Secondary outcomes (1)
Overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kostas N Syrigos, University of Athens
- Investigators
- Kostas N Syrigos, Professor, Study chair, Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963351
- Sponsor's protocol ID
- ML27816
- Status last verified
- Dec 2014
- First submitted
- 19 Sep 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01963351
- Acronym / sponsor ID
- ML27816
- Keywords
- NSCLC, Non-squamous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Oct 2013 (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.
This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.
Detailed description
It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced and metastatic nsclc | – | –non squamous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically or cytologically documented advanced metastatic (patients who are not candidates for radiotherapy, i.e. supraclavicular lymph node metastases or Stage IIIb with malignant pleural or pericardial effusion or Stage IV) or recurrent non-squamous non-small cell lung cancer.
Key inclusion criteria (7 listed)
- 1. Written informed consent 2. Age ≥18 years 3. Able to comply with the protocol 4. Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2 6. Life expectancy ≥12 weeks 7. Adequate haematological function:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
- Platelet count ≥100 x 109/L AND
- Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level) 8. Adequate liver function:
- Total bilirubin <1.5 x upper limit of normal (ULN) AND
Key exclusion criteria (17 listed)
- Mixed, predominant squamous component
- History of haemoptysis, in the 3 months prior to enrolment
- Evidence of tumour invading major blood vessels
- Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse events during 24 months of follow-up
Time frame: 24 months
1 secondary outcome
Overall survival
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Kostas N Syrigos, Professor study chair
Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Unresectable Malignant Neoplasm, run by University of Athens at 1 site 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 17 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: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events during 24 months of follow-up (time frame: 24 months). 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 8 Dec 2014.