Carcinoma, Non-Small-Cell LungPhase 2NCT00313768
Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC
A Phase 2 study testing paclitaxel + carboplatin + bevacizumab and carboplatin + paclitaxel + bevacizumab + PF-3512676 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 29 sites in United States.
Trial summary
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- paclitaxel + carboplatin + bevacizumab and carboplatin + paclitaxel + bevacizumab + PF-3512676
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 29 sitesUnited States
- Study dates
- Dec 2005to May 2008
- 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 IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer
- ECOG Performance Status 0-1
- Measurable disease per RECIST criteria
Who cannot join
- Squamous cell, small cell, or carcinoid lung cancer
- CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
- Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78745
Pfizer Investigational Site
Austin, Texas, 78758
Pfizer Investigational Site
Austin, Texas, 78759
Pfizer Investigational Site
Baltimore, Maryland, 21231
Pfizer Investigational Site
Bessemer, Alabama, 35022
Pfizer Investigational Site
Birmingham, Alabama, 32511
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Birmingham, Alabama, 35213
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Clinton, North Carolina, 28382
Pfizer Investigational Site
Cocoa Beach, Florida, 32931
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Georgetown, Texas, 78626
Pfizer Investigational Site
Goldsboro, North Carolina, 27534
Pfizer Investigational Site
Joliet, Illinois, 60432
Pfizer Investigational Site
Joliet, Illinois, 60435
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Knoxville, Tennessee, 37934
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Merritt Island, Florida, 32952
Pfizer Investigational Site
Mobile, Alabama, 36607
Pfizer Investigational Site
Pollocksville, North Carolina, 28573
Pfizer Investigational Site
Rockledge, Florida, 32955
Pfizer Investigational Site
San Marcos, Texas, 78666
Pfizer Investigational Site
Titusville, Florida, 32796
Pfizer Investigational Site
Valdosta, Georgia, 31602
Pfizer Investigational Site
Wilson, North Carolina, 27893
About this study
Official title: A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Read the detailed description
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. the decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 22 May 2008.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- paclitaxel + carboplatin + bevacizumab, carboplatin + paclitaxel + bevacizumab + PF-3512676
- Keywords
- advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator
- 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 + bevacizumabDrug
Also called Taxol; Paraplatin
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
carboplatin + paclitaxel + bevacizumab + PF-3512676Drug
Also called Paraplatin; Taxol; Avastin
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Standard of care chemotherapy Receives: Drug: paclitaxel + carboplatin + bevacizumab |
| A | Experimental | Standard of care chemotherapy plus experimental intervention (PF-3512676) Receives: Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 110 Events
Secondary outcomes (5)
Time to Tumor Progression
Measured: End of treatment
Overall Objective Response Rate
Measured: Time of progressive disease
Duration of Response
Measured: Time of progression
Overall Survival
Measured: Time of death
Overall safety profile
Measured: 28 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: See Termination Reason in Detailed Description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313768
- Sponsor's protocol ID
- A8501003
- Status last verified
- Sep 2009
- First submitted
- 10 Apr 2006
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00313768
- Acronym / sponsor ID
- A8501003
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Termination Reason in Detailed Description.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Apr 2006 (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.
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Detailed description
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. the decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 22 May 2008.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: paclitaxel + carboplatin + bevacizumabStandard of care chemotherapy |
| A | Experimental | Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676Standard of care chemotherapy plus experimental intervention (PF-3512676) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer
- ECOG Performance Status 0-1
- Measurable disease per RECIST criteria
Key exclusion criteria (4 listed)
- Squamous cell, small cell, or carcinoid lung cancer
- CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
- Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs
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 + bevacizumabAlso: Taxol; Paraplatinpaclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles | Drug | B |
| carboplatin + paclitaxel + bevacizumab + PF-3512676Also: Paraplatin; Taxol; Avastincarboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles | Drug | A |
Primary outcome
Progression-free survival
Time frame: 110 Events
5 secondary outcomes
Time to Tumor Progression
Time frame: End of treatment
Overall Objective Response Rate
Time frame: Time of progressive disease
Duration of Response
Time frame: Time of progression
Overall Survival
Time frame: Time of death
Overall safety profile
Time frame: 28 days post treatment
Results and safety
The study was stopped early (reason given: See Termination Reason in Detailed Description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
29 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 paclitaxel + carboplatin + bevacizumab and carboplatin + paclitaxel + bevacizumab + PF-3512676 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 29 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 was stopped early (reason given: See Termination Reason in Detailed Description.). Results are not available in the source record.
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 (time frame: 110 Events). 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 28 Sep 2009.