Carcinoma, Non-Small-Cell LungPhase 2NSCLCNCT00553800
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing bevacizumab and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Fox Chase Cancer Center at 7 sites in United States.
Trial summary
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- bevacizumab and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Jul 2007to 1 Jun 2011
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- ECOG PS 0-1
- 70 years of age or older
- Must have measurable disease
- ANC > 1500, platelets > 100,000
- Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN
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- Able and willing to swallow and absorb oral medication
- Able and willing to sign consent
- Request archival diagnostic tissue for EGFR expression but not required
Who cannot join
- Proteinuria as demonstrated by UPC ratio >/= 1.0
- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
- Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
- History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
- Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
- Current, ongoing treatment with full dose warfarin or equivalent
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- Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet activity
- History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
- Known CNS disease except for treated brain mets.
- Squamous cell histology
- Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives
- History of hypertensive crisis or hypertensive encephalopathy
- NYHA grade II or > CHF
- History of MI within 6 months of enrollment
- Major surgery, open biopsy, significant trauma within 28 days of enrollment
- Pregnancy, lactation
- Abdominal or other fistula, abcess, perforation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
AtlantiCare Regional Medical Center
Galloway, New Jersey, 08205
Fox Chase Virtua Health Cancer Program at Memorial
Mount Holly, New Jersey, 08060
Paoli Hospital
Paoli, Pennsylvania, 19301
Abramson Cnacer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Grand View Hospital
Sellersville, Pennsylvania, 18960
About this study
Official title: Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
Read the detailed description
There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- bevacizumab, Erlotinib
- 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.
bevacizumabDrug
Also called Other names: Avastin
ErlotinibDrug
Also called Other name: Tarceva
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab & Erlotinib | Experimental | bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day Receives: Drug: bevacizumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study start5 Jul 2007
- Primary completion12 Jan 2011
- Study completion1 Jun 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Hossein Borghaei, DO, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553800
- Sponsor's protocol ID
- FER-TH-007
- Acronym
- NSCLC
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2007
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Phase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
- ClinicalTrials.gov ID
- NCT00553800
- Acronym / sponsor ID
- NSCLC / FER-TH-007
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Study start
- 5 Jul 2007 (actual)
- Primary completion
- 12 Jan 2011 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Posted 12 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
Detailed description
There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab & Erlotinib | Experimental | Drug: bevacizumab, Drug: Erlotinibbevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- ECOG PS 0-1
- 70 years of age or older
- Must have measurable disease
- ANC > 1500, platelets > 100,000
Key exclusion criteria (17 listed)
- Proteinuria as demonstrated by UPC ratio >/= 1.0
- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
- Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
- History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
- Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
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 |
|---|---|---|
| bevacizumabAlso: Other names: Avastin | Drug | Bevacizumab & Erlotinib |
| ErlotinibAlso: Other name: Tarceva | Drug | Bevacizumab & Erlotinib |
Primary outcome
Progression Free Survival (PFS)
Time frame: 3 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundPhase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019
- Individual participant dataSharing planned: No
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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.
Hossein Borghaei, DO principal investigator
Fox Chase Cancer Center
7 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 bevacizumab and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Fox Chase Cancer Center at 7 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 9 inclusion and 17 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 12 Jul 2022). 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: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553800, which also lists 1 linked publication.
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 12 Jul 2022.