Nonsquamous Nonsmall Cell Neoplasm of LungANGIOMETNCT01814163
Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Spanish Lung Cancer Group at 20 sites in Spain.
Trial summary
This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- paclitaxel, carboplatin and bevacizumab
- How many people
- 200 participants
- Where
- 20 sitesSpain
- Study dates
- Feb 2011to Feb 2013
- 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 non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy
Who may be able to join
- Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
- Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
- Patients age 18 years or more
- Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
- Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
- Patients must be avalaible for clinical follow-up
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- Patients with the following hematologic/biochemical values:
- Absolute Neutrophil Count ANC > 1500/µl.
- Platelets > 100.000 /µl.
- Hemoglobine > 10 g/dl.
- Bilirrubin < 1.5 mg/dl.
- Aspartate aminotransfereasa (AST) and Alanine transaminase (ALT) ≤ 3 x LSN, except in case of hepatic metastases: upper 5 x LSN
- Creatinine clearance ≥ 45 ml/min.
Who cannot join
- Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment
- history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
- evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
- Known or suspected brain metastases non-treated.
- Major surgery within 28 days of starting treatment.
- Minor surgery within 24 hours before starting the treatment.
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- Non-controlled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
- Patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study.
- History or evidence of bleeding diathesis or hereditary coagulopathy.
- Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab.
- Patients who are pregnant or breasfeeding. Women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment.
- Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
H. Gen. Universitario Alicante
Alicante, Alicante
Hospital Provincial de Castellón
Castellon
Hospital General de Elche
Elche (Alicante)
Hospital General de L'Hospitalet
l'Hospitalet (Barcelona)
Hospital Insular Gran Canaria
Las Palmas
H. Clínico San Carlos
Madrid, Madrid
H. La Paz
Madrid, Madrid
Clínica Quirón
Madrid
Fundacion Jiménez Díaz
Madrid
Hospital Gregorio Marañon
Madrid
Hospital Puerta de Hierro
Majadahonda (Madrid)
Clinica Rotger
Palma de Mallorca
Hospital Son Espases
Palma de Mallorca
Hospital Ntra Sra Candelaria
Santa Cruz de Tenerife
Hospital Universitario Canarias
Santa Cruz de Tenerife
H. Gen. Univ. Valencia
Valencia, Valencia
Hospital Arnau de Vilanova
Valencia
Hospital Dr. Peset
Valencia
Hospital La Fe
Valencia
Hospital Miguel Servet
Zaragoza
About this study
Official title: Observational Studies to Explore the Relation Between Angiogenic Markers and the Treatment Response With Carboplatin, Paclitaxel and Bevacizumab in First Line of Advanced Non-small-cell Lung Cancer With Non- Squamous Histology
This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.
Read the detailed description
This is a observational study prospectively followed post-authorization.
- Being tested
- paclitaxel, carboplatin and bevacizumab
- Keywords
- First line treatment, Non small cell lung cancer, 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.
paclitaxel, carboplatin and bevacizumabDrug
Also called Taxol, carboplatin, avastin
Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, carboplatin and bevacizumab | Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression Receives: Drug: paclitaxel, carboplatin and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between angiogenesis markers and progression free survival.
Measured: 1 year
Secondary outcomes (5)
Overal survival
Measured: 3 year
Survival at 12 and 24 months
Measured: 12-24 months
Objective response
Measured: 24 months
Duration of response
Measured: 24 months
Treatment security
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 posted19 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartomeu Massutí, MD, Study chair, H. Gen. Univ.AlicanteCarlos Camps, MD, Study chair, H. Gen. Univ. ValenciaJavier de Castro, MD, Study chair, H. La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814163
- Sponsor's protocol ID
- GECP 09-02
- Acronym
- ANGIOMET
- Status last verified
- Mar 2013
- First submitted
- 18 Jul 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies to Explore the Relation Between Angiogenic Markers and the Treatment Response With Carboplatin, Paclitaxel and Bevacizumab in First Line of Advanced Non-small-cell Lung Cancer With Non- Squamous Histology
- ClinicalTrials.gov ID
- NCT01814163
- Acronym / sponsor ID
- ANGIOMET / GECP 09-02
- Keywords
- First line treatment, Non small cell lung cancer, non squamous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Mar 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 is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.
Detailed description
This is a observational study prospectively followed post-authorization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, carboplatin and bevacizumab | – | Drug: paclitaxel, carboplatin and bevacizumabPaclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer advanced unresectable, metastatic or recurrent, non-squamous and untreated with chemotherapy
Key inclusion criteria (13 listed)
- Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
- Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
- Patients age 18 years or more
- Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
- Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
Key exclusion criteria (12 listed)
- Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment
- history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
- evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
- Known or suspected brain metastases non-treated.
- Major surgery within 28 days of starting treatment.
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 |
|---|---|---|
| paclitaxel, carboplatin and bevacizumabAlso: Taxol, carboplatin, avastinPaclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression | Drug | Paclitaxel, carboplatin and bevacizumab |
Primary outcome
Correlation between angiogenesis markers and progression free survival.
Time frame: 1 year
5 secondary outcomes
Overal survival
Time frame: 3 year
Survival at 12 and 24 months
Time frame: 12-24 months
Objective response
Time frame: 24 months
Duration of response
Time frame: 24 months
Treatment security
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 19 Mar 2013.
- Spanish Lung Cancer Group websiteLink provided by the sponsor.
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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.
Bartomeu Massutí, MD study chair
H. Gen. Univ.Alicante
Carlos Camps, MD study chair
H. Gen. Univ. Valencia
Javier de Castro, MD study chair
H. La Paz
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Spanish Lung Cancer Group at 20 sites in Spain.
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 13 inclusion and 12 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 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
Correlation between angiogenesis markers and progression free survival. (time frame: 1 year). 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 19 Mar 2013.