Lung CancerPhase 2NCT00367601
Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
A Phase 2 study testing Erlotinib and Bevacizumab in people with Lung Cancer, run by Nasser Hanna, M.D. at 13 sites in United States.
Trial summary
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Erlotinib and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2006to Dec 2008
- 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
- Histological proof of non-small cell lung cancer meeting one of the following criteria:
- stage III b with a pleural effusion
- stage IV
- Histology must not be squamous cell.
- No prior chemotherapy or hormonal therapy.
- Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy.
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- No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic agent.
- No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
- Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
- ECOG Performance Status of 2 in the opinion of the treating investigator.
- Age > 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 6 week period thereafter.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Females must not be breastfeeding.
- Able to comply with study and/or follow-up procedures.
Who cannot join
- Evidence of bleeding diathesis or coagulopathy.
- Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
- Anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
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- Serious, non-healing wound, ulcer, or bone fracture.
- History of hemoptysis.
- Clinically significant infections as judged by the treating investigator.
- Other active malignancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Oncology Partners Network
Cincinnati, Ohio, 45247
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
Medical Consultants, P.C.
Muncie, Indiana, 47303
Methodist Cancer Center
Omaha, Nebraska, 68114
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
Official title: A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.
Read the detailed description
OUTLINE: This is a multi-center study.
- Bevacizumab 15 mg/kg IV on day 1
- Erlotinib 150 mg po qd days 1-21
- Disease Assessment during even numbered cycles
If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease.
If progressive disease observed, treatment will be discontinued.
- Cycles will be repeated every 21 days up to a total of 6 cycles.
- Patients with non-progression after 6 cycles may stay on therapy (single agent erlotinib or the combination) until progressive disease or intolerable toxicity (at the physician discretion).
- Patients who require discontinuation of bevacizumab may receive at investigator's discretion erlotinib alone on study until progression.
- Patients who require discontinuation of erlotinib may receive at investigator's discretion bevacizumab alone until progression.
ECOG Performance Status 2
Hematopoietic:
- Absolute neutrophil count (ANC) > 1,000 mm3
- Platelet count > 100,000 mm3
- Hemoglobin > 8 g/dl
Hepatic:
- Bilirubin < 2 X upper limit of normal.
- Aspartate aminotransferase (AST, SGOT) < 2.5 X upper limit of normal or 5 X if liver involvement.
Renal:
- Urine protein:creatinine ratio 1.0 at screening
Cardiovascular:
- Blood pressure of < 150/100 mmHg.
- No history of unstable angina.
- No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- No history of myocardial infarction within 6 months prior to registration for protocol therapy.
- No history of stroke within 6 months prior to registration for protocol therapy.
- No clinically significant peripheral vascular disease.
- Conditions
- Lung Cancer
- Being tested
- Erlotinib, Bevacizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Erlotinib 150 mg qd days 1-21
BevacizumabDrug
Bevacizumab 15 mg/kg IV, day 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease. Receives: Drug: Erlotinib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
Measured: 4 months
Secondary outcomes (2)
Time to Progression
Measured: 12 months
Overall Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionDec 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Walther Cancer Institute, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367601
- Sponsor's protocol ID
- HOG LUN04-77
- Status last verified
- Jan 2016
- First submitted
- 21 Aug 2006
- Last updated
- 11 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
T. Al Baghdadi, S. Bhatia, W. Harb, J. Maher, J. McClean, S. Nattam, D. Taber, M. Yu, C. Johnson and N. Hanna. Erlotinib and bevacizumab in chemotherapy naïve performance status 2 patients with advanced non-small-cell lung cancer. Accepted (abstract #e19082) at the ASCO annual meeting May 29-June 2, 2009, Orlando, FL
Riggs H, Jalal SI, Baghdadi TA, Bhatia S, McClean J, Johnson C, Yu M, Taber D, Harb W, Hanna N. Erlotinib and bevacizumab in newly diagnosed performance status 2 or elderly patients with nonsquamous non-small-cell lung cancer, a phase II study of the Hoosier Oncology Group: LUN04-77. Clin Lung Cancer. 2013 May;14(3):224-9. doi: 10.1016/j.cllc.2012.09.004. Epub 2012 Oct 24.
PubMed 23102811
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00367601
- Acronym / sponsor ID
- HOG LUN04-77
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nasser Hanna, M.D.University, hospital or other
- Collaborators
- Genentech, Inc., Walther Cancer Institute, Hoosier Cancer Research Network
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Posted 11 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.
Detailed description
OUTLINE: This is a multi-center study.
- Bevacizumab 15 mg/kg IV on day 1
- Erlotinib 150 mg po qd days 1-21
- Disease Assessment during even numbered cycles
If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease.
If progressive disease observed, treatment will be discontinued.
- Cycles will be repeated every 21 days up to a total of 6 cycles.
- Patients with non-progression after 6 cycles may stay on therapy (single agent erlotinib or the combination) until progressive disease or intolerable toxicity (at the physician discretion).
- Patients who require discontinuation of bevacizumab may receive at investigator's discretion erlotinib alone on study until progression.
- Patients who require discontinuation of erlotinib may receive at investigator's discretion bevacizumab alone until progression.
ECOG Performance Status 2
Hematopoietic:
- Absolute neutrophil count (ANC) > 1,000 mm3
- Platelet count > 100,000 mm3
- Hemoglobin > 8 g/dl
Hepatic:
- Bilirubin < 2 X upper limit of normal.
- Aspartate aminotransferase (AST, SGOT) < 2.5 X upper limit of normal or 5 X if liver involvement.
Renal:
- Urine protein:creatinine ratio 1.0 at screening
Cardiovascular:
- Blood pressure of < 150/100 mmHg.
- No history of unstable angina.
- No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- No history of myocardial infarction within 6 months prior to registration for protocol therapy.
- No history of stroke within 6 months prior to registration for protocol therapy.
- No clinically significant peripheral vascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Erlotinib, Drug: BevacizumabBevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological proof of non-small cell lung cancer meeting one of the following criteria:
- Histology must not be squamous cell.
- No prior chemotherapy or hormonal therapy.
- Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy.
- No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic agent.
Key exclusion criteria (10 listed)
- Evidence of bleeding diathesis or coagulopathy.
- Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
- Anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
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 |
|---|---|---|
| ErlotinibErlotinib 150 mg qd days 1-21 | Drug | 1 |
| BevacizumabBevacizumab 15 mg/kg IV, day 1 | Drug | 1 |
Primary outcome
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
Time frame: 4 months
2 secondary outcomes
Time to Progression
Time frame: 12 months
Overall Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationT. Al Baghdadi, S. Bhatia, W. Harb, J. Maher, J. McClean, S. Nattam, D. Taber, M. Yu, C. Johnson and N. Hanna. Erlotinib and bevacizumab in chemotherapy naïve performance status 2 patients with advanced non-small-cell lung cancer. Accepted (abstract #e19082) at the ASCO annual meeting May 29-June 2, 2009, Orlando, FL
- Results publication: PubMed 23102811Riggs H, Jalal SI, Baghdadi TA, Bhatia S, McClean J, Johnson C, Yu M, Taber D, Harb W, Hanna N. Erlotinib and bevacizumab in newly diagnosed performance status 2 or elderly patients with nonsquamous non-small-cell lung cancer, a phase II study of the Hoosier Oncology Group: LUN04-77. Clin Lung Cancer. 2013 May;14(3):224-9. doi: 10.1016/j.cllc.2012.09.004. Epub 2012 Oct 24.
- Hoosier Oncology Group Home PageLink 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.
Nasser Hanna, M.D. study chair
Hoosier Oncology Group, LLC
13 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 Erlotinib and Bevacizumab in people with Lung Cancer, run by Nasser Hanna, M.D. at 13 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 15 inclusion and 10 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 11 Feb 2016). 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?
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician (time frame: 4 months). 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 NCT00367601, which also lists 2 linked publications.
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 Feb 2016.