Small Cell Lung CancerPhase 2NCT00403403
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
A Phase 2 study testing Bevacizumab and Chemotherapy in people with Small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Bevacizumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jun 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
- Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
- Measurable disease or lesions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Who cannot join
- Life expectancy of < 12 weeks
- Current, recent, or planned participation in another experimental drug study
- Ongoing or active infection
- Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
- Prior systemic therapy, radiation therapy, or surgery for SCLC
- Inadequate bone marrow function, renal function, or hepatic function
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- Serum sodium of < 120 mg/dL
- Inadequately controlled hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Class II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Known central nervous system disease, except for brain metastases treated with whole-brain radiotherapy
- Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to study enrollment
- History of hemoptysis within 4 weeks prior to study enrollment
- Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of a need for a major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to study enrollment
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Known hypersensitivity to any component of bevacizumab
- Pregnant (positive pregnancy test) or lactating
About this study
Official title: A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
- Conditions
- Small Cell Lung Cancer
- Being tested
- Bevacizumab, Chemotherapy, Placebo
- Keywords
- SCLC, SALUTE, Lung Cancer, Avastin
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
ChemotherapyDrug
Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
PlaceboDrug
Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
| Study group | Role | What they receive |
|---|---|---|
| Placebo+Chemotherapy | Placebo comparator | Chemotherapy = cisplatin (or carboplatin) + etoposide Receives: Drug: Chemotherapy; Drug: Placebo |
| Bevacizumab+Chemotherapy | Experimental | Chemotherapy = cisplatin (or carboplatin) + etoposide Receives: Drug: Bevacizumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Measured: Randomization until progression or lost to follow-up (up to 2 years)
Secondary outcomes (4)
Overall Survival
Duration of overall survival from randomization until death or loss to follow-up
Measured: Randomization until death or lost of follow-up (up to 27 months)
Percentage of Participants With an Objective Response
Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):
Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Measured: Randomization until progression or lost to follow-up (up to 2 years)
Number of Participants With an Objective Response
Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):
Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Measured: Randomization until progression or lost to follow-up (up to 2 years)
Duration of Objective Response
Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.
Measured: Randomization until progression or lost to follow-up (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startMar 2007
- Primary completionFeb 2009
- Study completionJun 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Karlin, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403403
- Sponsor's protocol ID
- AVF3995g
- Status last verified
- Apr 2011
- First submitted
- 21 Nov 2006
- Last updated
- 29 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00403403
- Acronym / sponsor ID
- AVF3995g
- Conditions
- Small Cell Lung Cancer
- Keywords
- SCLC, SALUTE, Lung Cancer, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Posted 25 Feb 2011
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 placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo+Chemotherapy | Placebo comparator | Drug: Chemotherapy, Drug: PlaceboChemotherapy = cisplatin (or carboplatin) + etoposide |
| Bevacizumab+Chemotherapy | Experimental | Drug: Bevacizumab, Drug: ChemotherapyChemotherapy = cisplatin (or carboplatin) + etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
- Measurable disease or lesions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Key exclusion criteria (22 listed)
- Life expectancy of < 12 weeks
- Current, recent, or planned participation in another experimental drug study
- Ongoing or active infection
- Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
- Prior systemic therapy, radiation therapy, or surgery for SCLC
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 |
|---|---|---|
| BevacizumabBevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. | Drug | Bevacizumab+Chemotherapy |
| ChemotherapyChemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. | Drug | Bevacizumab+Chemotherapy, Placebo+Chemotherapy |
| PlaceboPlacebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. | Drug | Placebo+Chemotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: Randomization until progression or lost to follow-up (up to 2 years)
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
4 secondary outcomes
Overall Survival
Time frame: Randomization until death or lost of follow-up (up to 27 months)
Percentage of Participants With an Objective Response
Time frame: Randomization until progression or lost to follow-up (up to 2 years)
Number of Participants With an Objective Response
Time frame: Randomization until progression or lost to follow-up (up to 2 years)
Duration of Objective Response
Time frame: Randomization until progression or lost to follow-up (up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
- 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.
David Karlin, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Chemotherapy in people with 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 3 inclusion and 22 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 29 Apr 2011. 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. Some participants in this study may receive a placebo. 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 25 Feb 2011). 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?
Progression-free Survival (PFS) (time frame: Randomization until progression or lost to follow-up (up to 2 years)). 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 29 Apr 2011.