Head and Neck CancerPhase 1NCT00779389
Comparison of Biomarker Modulation by Inhibition of EGFR and/or SRC Family
A Phase 1 study testing Erlotinib and Erlotinib plus Dasatinib in people with Head and Neck Cancer and Non Small Cell Lung Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Erlotinib and Erlotinib plus Dasatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2014
- Phase
- Phase 1
- 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
- Histologically or cytologically confirmed, head and neck or lung cancers
- Any NSCLC histology is eligible. Stages I, II, IIIA (T3N1 only) or recurrent NSCLC that will be managed with surgery are eligible.
- Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) or lung site will be included.
- Surgical resection of head and neck or lung must be planned, either as primary treatment or salvage. Patients must have tissue available prior to receiving drug(s).
- Age greater then 18 years.
- ECOG performance status 0-2.
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- Women of childbearing potential (WOCBP) must have:
- A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
- Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
- Ability to take oral medication (dasatinib must be swallowed whole).
- Concomitant Medications
- Patients agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib).
- Patient agrees that IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
- Adequate hematologic, renal and hepatic function.
- Have signed written informed consent including a HIPPA form according to institutional guidelines.
Who cannot join
- Subjects who fail to meet the above criteria.
- Prior therapy for head and neck or lung cancers is allowed, with the exception of EGFR inhibitors. Any systemic therapy should have been completed at least 30 days prior to study enrollment.
- Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
- Any unresolved chronic toxicity grade greater or equal to 2 from previous anticancer therapy (except alopecia and anemia).
- Acute hepatitis, known HIV, or active uncontrolled infection.
- Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.
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- Prior treatment with an EGFR inhibitor (tyrosine kinase inhibitor).
- Cardiac Symptoms; any of the following should be considered for exclusion:
- History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin is eligible.
- History of any other cancer except basal cell carcinoma of the skin.
- Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
- Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding.
- Concomitant Medications, any of the following should be considered for exclusion:
- Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
- Women who:
- are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug,
- have a positive pregnancy test at baseline, or
- are pregnant or breastfeeding.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers
The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
Read the detailed description
Background Head and neck squamous cell carcinoma (HNSCC) constitutes 3% of all malignancies and is the sixth most common malignancy worldwide. There will be an estimated 40,000 new cases and 11,000 deaths in the United States in 2007 and approximately 500,000 cases worldwide yearly [1]. Squamous cell carcinoma accounts for at least 90% of all head and neck cancers. Surgical resection remains a standard treatment for patients with resectable HNSCC. For patients with high risk of local or distant relapse, radiation therapy (RT) alone, or in combination with chemotherapy, is given after surgery to improve loco-regional control and overall survival. Moreover, surgery often represents the only curative option in patients who relapse locoregionally. Non-small cell lung cancer (NSCLC) is the leading cause of death worldwide. NSCLC is infrequently diagnosed when the cancer can be eradicated with surgical extirpation.
Specific Aims
- To determine the modulation of biomarkers by EGFR and/or Src targeting in head and neck and lung cancers.
- To determine if biomarker modulation is associated with reduction of tumor volume and/or evidence of histologic response in the tumor (e.g. decreased proliferation and/or decreased apoptosis) as well as safety and tolerability.
Subject population Patients will be accrued from head and neck and lung cancer patients who are surgical candidates. Surgery will be the primary curative treatment for patients enrolled in this study. Patients should not require any standard induction treatment prior to surgery. Surgery will have to be the best treatment option as determined by the treating physician. Therefore, we will not be delaying chemoradiotherapy or other curative treatment. We plan to include any stage of HNSCC or NSCLC that will be managed by primary surgery. If surgery is unexpectedly cancelled, the patient will be removed from the study unless there is an accessible lesion for biopsy. Ideally, the pre-treatment biopsy and the intraoperative sample will be obtained from the same site (when there are multiple lesions). Please see Section 3.0 for detailed eligibility criteria.
Treatment Plan The study drug or placebo will be taken for 14-21 days, and will be discontinued one day prior to planned surgical resection. If surgery is delayed, the study drug or placebo will be continued until one day prior to surgery, for up to a maximum of 28 days. Seven days is the minimum treatment for the patients to be evaluated. The interval between the last dose of experimental drug and surgery will be 12-36 hours. Please see Section 5.0 for treatment plan details. If the combination of erlotinib and dasatinib results in toxicity leading to a delay in surgery, the study will be terminated.
Statistical design and sample size This is a 4-arm randomized trial that is intended to estimate the effects of short-term preoperative therapy with EGFR and Src inhibitors upon a panel of biomarkers. The 4 treatment arms are erlotinib, dasatinib, their combination, and a placebo. We anticipate accruing 56 evaluable patients (14 patients per arm).
- Conditions
- Head and Neck Cancer, Non Small Cell Lung Cancer
- Being tested
- Erlotinib, Dasatinib + Placebo, Erlotinib plus Dasatinib, Placebo
- Keywords
- Head and Neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Erlotinib 150mg will be taken once a day for 14-21days.
Dasatinib + PlaceboDrug
Also called Sprycel
Dasatinib (100 mg) once a day for 14-21 days.
Erlotinib plus DasatinibDrug
Also called Tarceva and Sprycel
Erlotinib (150 mg PO qD) plus Dasatinib (100 mg PO qD) 14-21 days
PlaceboDrug
Placebo for 14-21 days.
ErlotinibDrug
Also called Tarceva
Erlotinib 150 mg for 14-21 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Erlotinib 150 mg Receives: Drug: Erlotinib |
| Arm B | Experimental | Dasatinib + placebo Receives: Drug: Dasatinib + Placebo |
| Arm C | Experimental | Erlotinib (150 mg) plus Dasatinib (100 mg) for 14-21 days. Receives: Drug: Erlotinib plus Dasatinib |
| Arm D | Placebo comparator | Placebo for 14-21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs.
Measured: 2-3 week preoperative period of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer R Grandis, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779389
- Sponsor's protocol ID
- 07-124
- Status last verified
- Feb 2015
- First submitted
- 22 Oct 2008
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauman JE, Duvvuri U, Gooding WE, Rath TJ, Gross ND, Song J, Jimeno A, Yarbrough WG, Johnson FM, Wang L, Chiosea S, Sen M, Kass J, Johnson JT, Ferris RL, Kim S, Hirsch FR, Ellison K, Flaherty JT, Mills GB, Grandis JR. Randomized, placebo-controlled window trial of EGFR, Src, or combined blockade in head and neck cancer. JCI Insight. 2017 Mar 23;2(6):e90449. doi: 10.1172/jci.insight.90449.
PubMed 28352657Van Allen EM, Lui VW, Egloff AM, Goetz EM, Li H, Johnson JT, Duvvuri U, Bauman JE, Stransky N, Zeng Y, Gilbert BR, Pendleton KP, Wang L, Chiosea S, Sougnez C, Wagle N, Zhang F, Du Y, Close D, Johnston PA, McKenna A, Carter SL, Golub TR, Getz G, Mills GB, Garraway LA, Grandis JR. Genomic Correlate of Exceptional Erlotinib Response in Head and Neck Squamous Cell Carcinoma. JAMA Oncol. 2015 May;1(2):238-44. doi: 10.1001/jamaoncol.2015.34.
PubMed 26181029Gross ND, Bauman JE, Gooding WE, Denq W, Thomas SM, Wang L, Chiosea S, Hood BL, Flint MS, Sun M, Conrads TP, Ferris RL, Johnson JT, Kim S, Argiris A, Wirth L, Nikiforova MN, Siegfried JM, Grandis JR. Erlotinib, erlotinib-sulindac versus placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer. Clin Cancer Res. 2014 Jun 15;20(12):3289-98. doi: 10.1158/1078-0432.CCR-13-3360. Epub 2014 Apr 11.
PubMed 24727329
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers
- ClinicalTrials.gov ID
- NCT00779389
- Acronym / sponsor ID
- 07-124
- Conditions
- Head and Neck Cancer, Non Small Cell Lung Cancer
- Keywords
- Head and Neck cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Oct 2008 (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.
The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
Detailed description
Background Head and neck squamous cell carcinoma (HNSCC) constitutes 3% of all malignancies and is the sixth most common malignancy worldwide. There will be an estimated 40,000 new cases and 11,000 deaths in the United States in 2007 and approximately 500,000 cases worldwide yearly [1]. Squamous cell carcinoma accounts for at least 90% of all head and neck cancers. Surgical resection remains a standard treatment for patients with resectable HNSCC. For patients with high risk of local or distant relapse, radiation therapy (RT) alone, or in combination with chemotherapy, is given after surgery to improve loco-regional control and overall survival. Moreover, surgery often represents the only curative option in patients who relapse locoregionally. Non-small cell lung cancer (NSCLC) is the leading cause of death worldwide. NSCLC is infrequently diagnosed when the cancer can be eradicated with surgical extirpation.
Specific Aims
- To determine the modulation of biomarkers by EGFR and/or Src targeting in head and neck and lung cancers.
- To determine if biomarker modulation is associated with reduction of tumor volume and/or evidence of histologic response in the tumor (e.g. decreased proliferation and/or decreased apoptosis) as well as safety and tolerability.
Subject population Patients will be accrued from head and neck and lung cancer patients who are surgical candidates. Surgery will be the primary curative treatment for patients enrolled in this study. Patients should not require any standard induction treatment prior to surgery. Surgery will have to be the best treatment option as determined by the treating physician. Therefore, we will not be delaying chemoradiotherapy or other curative treatment. We plan to include any stage of HNSCC or NSCLC that will be managed by primary surgery. If surgery is unexpectedly cancelled, the patient will be removed from the study unless there is an accessible lesion for biopsy. Ideally, the pre-treatment biopsy and the intraoperative sample will be obtained from the same site (when there are multiple lesions). Please see Section 3.0 for detailed eligibility criteria.
Treatment Plan The study drug or placebo will be taken for 14-21 days, and will be discontinued one day prior to planned surgical resection. If surgery is delayed, the study drug or placebo will be continued until one day prior to surgery, for up to a maximum of 28 days. Seven days is the minimum treatment for the patients to be evaluated. The interval between the last dose of experimental drug and surgery will be 12-36 hours. Please see Section 5.0 for treatment plan details. If the combination of erlotinib and dasatinib results in toxicity leading to a delay in surgery, the study will be terminated.
Statistical design and sample size This is a 4-arm randomized trial that is intended to estimate the effects of short-term preoperative therapy with EGFR and Src inhibitors upon a panel of biomarkers. The 4 treatment arms are erlotinib, dasatinib, their combination, and a placebo. We anticipate accruing 56 evaluable patients (14 patients per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: ErlotinibErlotinib 150 mg |
| Arm B | Experimental | Drug: Dasatinib + PlaceboDasatinib + placebo |
| Arm C | Experimental | Drug: Erlotinib plus DasatinibErlotinib (150 mg) plus Dasatinib (100 mg) for 14-21 days. |
| Arm D | Placebo comparator | Drug: PlaceboPlacebo for 14-21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed, head and neck or lung cancers
- Any NSCLC histology is eligible. Stages I, II, IIIA (T3N1 only) or recurrent NSCLC that will be managed with surgery are eligible.
- Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) or lung site will be included.
- Surgical resection of head and neck or lung must be planned, either as primary treatment or salvage. Patients must have tissue available prior to receiving drug(s).
- Age greater then 18 years.
Key exclusion criteria (23 listed)
- Subjects who fail to meet the above criteria.
- Prior therapy for head and neck or lung cancers is allowed, with the exception of EGFR inhibitors. Any systemic therapy should have been completed at least 30 days prior to study enrollment.
- Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
- Any unresolved chronic toxicity grade greater or equal to 2 from previous anticancer therapy (except alopecia and anemia).
- Acute hepatitis, known HIV, or active uncontrolled infection.
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 |
|---|---|---|
| ErlotinibAlso: TarcevaErlotinib 150mg will be taken once a day for 14-21days. | Drug | Arm A |
| Dasatinib + PlaceboAlso: SprycelDasatinib (100 mg) once a day for 14-21 days. | Drug | Arm B |
| Erlotinib plus DasatinibAlso: Tarceva and SprycelErlotinib (150 mg PO qD) plus Dasatinib (100 mg PO qD) 14-21 days | Drug | Arm C |
| PlaceboPlacebo for 14-21 days. | Drug | Arm D |
| ErlotinibAlso: TarcevaErlotinib 150 mg for 14-21 days. | Drug | Arm A |
Primary outcome
The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs.
Time frame: 2-3 week preoperative period of drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 28352657Bauman JE, Duvvuri U, Gooding WE, Rath TJ, Gross ND, Song J, Jimeno A, Yarbrough WG, Johnson FM, Wang L, Chiosea S, Sen M, Kass J, Johnson JT, Ferris RL, Kim S, Hirsch FR, Ellison K, Flaherty JT, Mills GB, Grandis JR. Randomized, placebo-controlled window trial of EGFR, Src, or combined blockade in head and neck cancer. JCI Insight. 2017 Mar 23;2(6):e90449. doi: 10.1172/jci.insight.90449.
- Derived from this study: PubMed 26181029Van Allen EM, Lui VW, Egloff AM, Goetz EM, Li H, Johnson JT, Duvvuri U, Bauman JE, Stransky N, Zeng Y, Gilbert BR, Pendleton KP, Wang L, Chiosea S, Sougnez C, Wagle N, Zhang F, Du Y, Close D, Johnston PA, McKenna A, Carter SL, Golub TR, Getz G, Mills GB, Garraway LA, Grandis JR. Genomic Correlate of Exceptional Erlotinib Response in Head and Neck Squamous Cell Carcinoma. JAMA Oncol. 2015 May;1(2):238-44. doi: 10.1001/jamaoncol.2015.34.
- Derived from this study: PubMed 24727329Gross ND, Bauman JE, Gooding WE, Denq W, Thomas SM, Wang L, Chiosea S, Hood BL, Flint MS, Sun M, Conrads TP, Ferris RL, Johnson JT, Kim S, Argiris A, Wirth L, Nikiforova MN, Siegfried JM, Grandis JR. Erlotinib, erlotinib-sulindac versus placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer. Clin Cancer Res. 2014 Jun 15;20(12):3289-98. doi: 10.1158/1078-0432.CCR-13-3360. Epub 2014 Apr 11.
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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.
Jennifer R Grandis, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erlotinib and Erlotinib plus Dasatinib in people with Head and Neck Cancer and Non Small Cell Lung Cancer, run by University of Pittsburgh at 1 site 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 23 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs. (time frame: 2-3 week preoperative period of drug administration). 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 NCT00779389, which also lists 3 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 13 Jan 2016.