Locally Advanced Non-Small Cell Lung CancerPhase 2NCT00702975
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab,Erlotinib in people with Locally Advanced Non-Small Cell Lung Cancer and NSCLC, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer, NSCLC
- What is being tested?
- Paclitaxel, Carboplatin and Bevacizumab,Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Jun 2013
- 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
- Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV excluding squamous cell histology, with measurable or evaluable disease.
- No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
- Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
- Life expectancy of at least 3 months.
- ECOG Performance status 0-1 (see appendix 2)
- Age 18 or higher.
- Female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to start of study medication. All female patients of childbearing potential, and all male patients, must agree to use a medically acceptable method of contraception or agree to be abstinent throughout the treatment period and for 3 months after discontinuation of treatment
- Patients must have normal organ and marrow function
Who cannot join
- Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
- Known brain metastases (in case of clinical signs or symptoms of brain metastases radiological evaluation is mandatory).
- Prior treatment with bevacizumab or erlotinib.
- History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or erlotinib.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
- Concomitant chemotherapy, radiotherapy or investigational agents.
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- Evidence of bleeding diathesis or coagulopathy.
- Use of full dose anti-coagulant agents.
- Pregnant (positive pregnancy test) or lactating women.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start, anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to start.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start.
- Serious, non-healing wound, ulcer, or bone fracture.
- Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist.
- History of hemoptysis (bright red blood of 2.5 ml or more).
- Significant co-morbidities including:
- No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Patients diagnosed with a trachea-oesophageal fistula
- Another active malignancy except for non-melanoma skin cancers in the last 5 years.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Lung Centre Nijmegen Dekkerswald
Groesbeek, Gelderland, 6561 KE
About this study
Official title: A Phase II Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer, NSCLC
- Being tested
- Paclitaxel, Carboplatin and Bevacizumab,Erlotinib
- Keywords
- phase II, NSCLC, bevacizumab, erlotinib, metastatic NSCLC
- 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 Bevacizumab,ErlotinibDrug
Also called Carboplatin (L01XA02), Paxene (L01CD01), Avastin(L01XC07), Tarceva(L01XE03)
4 cycles (or less in case of progression) with carboplatin AUC 6 -paclitaxel 200mg/m2 -bevacizumab 15 mg/kg i.v. At (early) progress Bevacizumab 15 mg/kg i.v. q 21 days plus Erlotinib 150 mg/day orally
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate
Measured: at 18 weeks
Secondary outcomes (1)
Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR
Measured: at 6, 12 and 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Timmer-Bonte, MD, Phd, Principal investigator, UMCN st Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702975
- Sponsor's protocol ID
- ULCN0107
- Status last verified
- Apr 2012
- First submitted
- 19 Jun 2008
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT00702975
- Acronym / sponsor ID
- ULCN0107
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer, NSCLC
- Keywords
- phase II, NSCLC, bevacizumab, erlotinib, metastatic NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jun 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.
A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV excluding squamous cell histology, with measurable or evaluable disease.
- No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
- Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
- Life expectancy of at least 3 months.
- ECOG Performance status 0-1 (see appendix 2)
Key exclusion criteria (25 listed)
- Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
- Known brain metastases (in case of clinical signs or symptoms of brain metastases radiological evaluation is mandatory).
- Prior treatment with bevacizumab or erlotinib.
- History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or erlotinib.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
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 Bevacizumab,ErlotinibAlso: Carboplatin (L01XA02), Paxene (L01CD01), Avastin(L01XC07), Tarceva(L01XE03)4 cycles (or less in case of progression) with carboplatin AUC 6 -paclitaxel 200mg/m2 -bevacizumab 15 mg/kg i.v. At (early) progress Bevacizumab 15 mg/kg i.v. q 21 days plus Erlotinib 150 mg/day orally | Drug | – |
Primary outcome
Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate
Time frame: at 18 weeks
1 secondary outcome
Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR
Time frame: at 6, 12 and 27 weeks
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 15 Jul 2013.
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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.
J. Timmer-Bonte, MD, Phd principal investigator
UMCN st Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Carboplatin and Bevacizumab,Erlotinib in people with Locally Advanced Non-Small Cell Lung Cancer and NSCLC, run by Radboud University Medical Center at 1 site in Netherlands.
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 8 inclusion and 25 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 15 Jul 2013. 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 Netherlands. 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?
Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate (time frame: at 18 weeks). 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 15 Jul 2013.