Non-small Cell Lung CancerPhase 2NCT00318136
A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)
A Phase 2 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior… 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?
- Bevacizumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed Informed Consent Form(s)
- At least 18 years of age
- Advanced histologically or cytologically confirmed predominant squamous NSCLC
- Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases
- Prior treatment for CNS disease as deemed appropriate by the treating physician
- ECOG performance status 0, 1, or 2
- Measurable or evaluable disease
- Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men)
Who cannot join
- Prior chemotherapy for metastatic disease
- Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1
- Extrathoracic metastases as the only sites of disease
- Active malignancy other than lung cancer
- Current, recent, or planned participation in another experimental drug study
- Untreated brain metastases
Show all 26Show fewer
- Presence of intrathoracic lesion(s) with any cavitation
- Gross hemoptysis within 3 months prior to Day 1
- In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel
- Inadequately controlled hypertension
- Unstable angina or NYHA Grade II or greater CHF
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Myocardial infarction within 6 months prior to Day 1, Cycle 1
- Stroke within 6 months prior to Day 1, Cycle 1
- Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1
- History of significant vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Current, ongoing treatment with full-dose warfarin or its equivalent
- Current or recent use of aspirin (>325 mg/day)
- Known hypersensitivity to any components of bevacizumab
- Serious, non-healing wound, ulcer, or bone fracture
- UPC ratio ≥ 1.0
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study
- Pregnancy or lactation
- Inadequate organ function
- Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
About this study
Official title: A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Bevacizumab, Carboplatin, Paclitaxel
- Keywords
- BRIDGE, NSCLC, Lung Cancer, Avastin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
CarboplatinDrug
Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
PaclitaxelDrug
Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Treated with Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."
Measured: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Secondary outcomes (3)
Selected Adverse Events
Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.
Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.
Measured: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Adverse Events That Led to Discontinuation of Bevacizumab
Any treatment-emergent adverse event leading to study treatment discontinuation
Measured: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Progression-free Survival
Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.
Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leonardo Faoro, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318136
- Sponsor's protocol ID
- AVF3744g
- Status last verified
- May 2010
- First submitted
- 24 Apr 2006
- Last updated
- 11 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00318136
- Acronym / sponsor ID
- AVF3744g
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- BRIDGE, NSCLC, Lung Cancer, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Posted 6 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Bevacizumab | Experimental | Drug: Bevacizumab, Drug: Carboplatin, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form(s)
- At least 18 years of age
- Advanced histologically or cytologically confirmed predominant squamous NSCLC
- Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases
- Prior treatment for CNS disease as deemed appropriate by the treating physician
Key exclusion criteria (26 listed)
- Prior chemotherapy for metastatic disease
- Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1
- Extrathoracic metastases as the only sites of disease
- Active malignancy other than lung cancer
- Current, recent, or planned participation in another 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 |
|---|---|---|
| Bevacizumab15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3 | Drug | Treated with Bevacizumab |
| CarboplatinDose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles | Drug | Treated with Bevacizumab |
| PaclitaxelDose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles | Drug | Treated with Bevacizumab |
Primary outcome
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."
3 secondary outcomes
Selected Adverse Events
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Adverse Events That Led to Discontinuation of Bevacizumab
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Progression-free Survival
Time frame: Length of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leonardo Faoro, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Genentech, Inc..
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 26 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 11 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events (time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death). 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 11 May 2010.