Non Small Cell Lung CancerPhase 2NCT00753909
Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
A Phase 2 study testing Carboplatin, Bevacizumab and Paclitaxel in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, 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
- Non Small Cell Lung Cancer
- What is being tested?
- Carboplatin, Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesGreece
- Study dates
- Nov 2008to Oct 2016
- 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) or metastatic (stage IV) non-squamous NSCLC
- Non-squamous histologic type
- At least one and no more than two previous chemotherapy regimens for advanced or metastatic NSCLC
- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
- Age ≥ 18 years
- Performance status (WHO) 0-2
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- Life expectancy of at least 12 weeks
- Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL), liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)
- Patients must be able to understand the nature of this study
- Written informed consent
Who cannot join
- Previous therapy with paclitaxel in combination with carboplatin
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Pregnant or lactating women
- Any serious, uncontrolled comorbidity on the investigator's judgment
- Uncontrolled infection
- Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
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- Symptomatic neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
- Brain metastases, except if radiated and asymptomatic
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy to the only measurable lesion
- Proteinuria ≥ 500 mgr of protein daily
- Hemoptysis > 10 cc per event
- Clinically significant hematemesis
- Centrally located lesion or in contact with major vessels
- Pulmonary lesion with cavitation
- Documented hemorrhagic diathesis or coagulation disorder
- Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
- Thrombotic event within the previous 6 months
- Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
- Concurrent treatment with other anti-cancer drug
- Major surgical procedure within the previous 4 weeks
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis
Alexandroupoli
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Heraklion, Dep of Medical Oncology
Heraklion, Crete
State General Hospital of Larissa, Dep of Medical Oncology
Larissa
"Diabalkaniko" hospital, Thessaloniki
Thessaloniki
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, advanced non small cell lung cancer.
Read the detailed description
The addition of bevacizumab to paclitaxel plus carboplatin in the 1st line treatment of patients with advanced or metastatic non small cell lung cancer (NSCLC) provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. The combination of paclitaxel and carboplatin, administered every two weeks, has a favorable toxicity profile. This study will evaluate the addition of bevacizumab to a biweekly regimen of paclitaxel and carboplatin as 2nd or 3rd line therapy for NSCLC
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Carboplatin, Bevacizumab, Paclitaxel
- Keywords
- Non Small Cell Lung Cancer, Paclitaxel, Carboplatin, Bevacizumab
- 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.
CarboplatinDrug
Carboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles
BevacizumabDrug
Also called Avastin
Bevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression
PaclitaxelDrug
Also called Taxoprol, Paxene, Taxol
Paclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Paclitaxel/Carboplatin/Bevacizumab Receives: Drug: Carboplatin; Drug: Bevacizumab; Drug: Paclitaxel |
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 6th cycle)
Secondary outcomes (3)
Toxicity profile
Measured: Toxicity assessment of each chemotherapy cycle
Time to Tumor Progression
Measured: 1-year
Overall Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2016
- Study completionOct 2016
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Agelaki, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753909
- Sponsor's protocol ID
- CT/08.17
- Status last verified
- Oct 2016
- First submitted
- 16 Sep 2008
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel, Carboplatin Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00753909
- Acronym / sponsor ID
- CT/08.17
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Paclitaxel, Carboplatin, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 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.
This trial will evaluate the efficacy and safety of paclitaxel, carboplatin and bevacizumab combination, administered biweekly, in patients with pretreated, advanced non small cell lung cancer.
Detailed description
The addition of bevacizumab to paclitaxel plus carboplatin in the 1st line treatment of patients with advanced or metastatic non small cell lung cancer (NSCLC) provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. The combination of paclitaxel and carboplatin, administered every two weeks, has a favorable toxicity profile. This study will evaluate the addition of bevacizumab to a biweekly regimen of paclitaxel and carboplatin as 2nd or 3rd line therapy for NSCLC
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: Carboplatin, Drug: Bevacizumab, Drug: PaclitaxelPaclitaxel/Carboplatin/Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
- Non-squamous histologic type
- At least one and no more than two previous chemotherapy regimens for advanced or metastatic NSCLC
- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
- Age ≥ 18 years
Key exclusion criteria (21 listed)
- Previous therapy with paclitaxel in combination with carboplatin
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Pregnant or lactating women
- Any serious, uncontrolled comorbidity on the investigator's judgment
- Uncontrolled infection
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 |
|---|---|---|
| CarboplatinCarboplatin (IV) 3 AUC on day 1 and day 15 every 4 weeks for 6 cycles | Drug | 1 |
| BevacizumabAlso: AvastinBevacizumab (IV) 10 mg/kg on day 1 and day 15 every 4 weeks for 6 cycles Followed by Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks until disease progression | Drug | 1 |
| PaclitaxelAlso: Taxoprol, Paxene, TaxolPaclitaxel (IV) 140 mg/m2,on day 1 and day 15 every 4 weeks for 6 cycles | Drug | 1 |
Primary outcome
Overall Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
3 secondary outcomes
Toxicity profile
Time frame: Toxicity assessment of each chemotherapy cycle
Time to Tumor Progression
Time frame: 1-year
Overall Survival
Time frame: 1 year
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 4 Oct 2016.
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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
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 Carboplatin, Bevacizumab and Paclitaxel 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 10 inclusion and 21 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 4 Oct 2016. 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 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?
Overall Response Rate (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)). 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 4 Oct 2016.