- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00392665
Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
March 15, 2017 updated by: Lori J. Wirth, MD, Massachusetts General Hospital
Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
The main purpose of this research study is to collect information to learn how effective erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck.
Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells.
Erlotinib targets epidermal growth factor receptor (EGFR), and bevacizumab targets vascular endothelial growth factor (VEGF).
Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity.
The bevacizumab being administered in this study is not a commercially marketed formulation of the drug.
Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity.
This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
- Participants will be randomized to either Arm A: erlotinib plus bevacizumab, or Arm B: erlotinib plus sulindac. Participants will have an equal chance of being placed in any group.
- Medication on Arm A: erlotinib plus bevacizumab: Participants will take erlotinib pills orally once a day. Bevacizumab will be given intravenously on day one of each treatment cycle (each treatment cycle will last three weeks). Urine tests will be performed once every three weeks to test kidney function.
- Medication on Arm B: erlotinib plus sulindac: Participants will take erlotinib pills orally once a day. Sulindac will be taken orally twice a day.
- Physical exams will be performed during each treatment cycle and will include vital signs and general health questions. We will take the participants blood pressure every 2 weeks for the first 6 weeks. After that point, we will take it every 3 weeks or more often if necessary. Blood tests will be performed including chemistry and hematology.
- After every 2 cycles, a repeat CT scan, MRI, and/or PET scan will be performed along with either a chest x-ray or CT scan to ensure that there is no tumor in the participants lungs. We may also do a bone scan if there may be tumor in the participants bones, and abdominal CT scan if there may be tumor in the liver, and a head CT scan or MRI if there may be tumor in the brain.
- After the final treatment the participant will be seen in the clinic to see if they have had any side effects from the drugs within 30 days of stopping the drugs.
- Participants will be in this research study for as long as they are receiving clinical benefits from the study drugs, and do not develop excessive side effects or disease progression. After treatment is discontinued, we will follow the participant closely for 30 days and every 1-2 months after that.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically/cytologically documented SCCHN, excluding salivary gland primary sites
- 18 years of age or older
- Have evaluable locoregional and/or metastatic disease according to RECIST that is not appropriate for treatment by primary surgical resection or radiotherapy
- Have locoregional and/or metastatic disease that has failed to respond to or relapsed from at least one prior chemotherapy or chemoradiotherapy
- Life expectancy of at least 4 months
- ECOG performance status of 0-2
- Use of effective means of contraception in patients of child-bearing potential
Exclusion Criteria:
- Other malignancy within 5 years except non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder or head and neck
- Concurrent anticancer therapy other than that of this study
- Treatment with any anticancer drug within 28 days of day 1
- Radiotherapy within 28 days of day 1
- Any unresolved toxicity greater than NCI-CTCAE v 3.0 grade 2 from prior systemic anticancer therapy
- Any prior therapy that targets the ErbB and/or VEGF pathways
- Concurrent therapy with any NSAID
- Known hypersensitivity characterized by acute bronchospasm, urticaria and/or rhinitis to NSAIDs, including aspirin
- Serum creatinine > 1.5 x ULN
- Abnormal LFTs as outlined in protocol
- Blood pressure > 150/100mmHg
- Active unstable angina, or myocardial infarction within 6 months
- NYHA Grade II or greater congestive heart failure
- History of stroke within 6 months
- Clinically significant active peripheral vascular disease
- Absolute neutrophil count < 1000/mm3 or platelets < 100,000/mm3
- Evidence of bleeding diathesis or coagulopathy.
- Tumor encasing the carotid artery, or other major vessel that in the opinion of the investigators is at risk for tumor-related hemorrhage
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspiration or core biopsy within 5 days prior to day 1
- Pregnant or lactating
- History of abdominal fistula or intra-abdominal abscess within 6 months
- History of gastrointestinal ulcer, perforation, or bleeding within 6 months
- Serious non-healing wound or ulcer or active uncontrolled infection
- Bone fracture within 28 days
- Active substance abuse, defined by substance abuse of alcohol, cocaine or intravenous drug use within 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Erlotinib + Bevacizumab
erlotinib plus bevacizumab
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Given intravenously on day one of each 3 week cycle
Given orally once a day
Other Names:
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Active Comparator: Erlotinib + Sulindac
erlotinib plus sulindac
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Given orally once a day
Other Names:
Given orally twice a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.
Time Frame: 1 year
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The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. 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.
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 2 years
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Overall response rate (complete plus partial response=ORR), as determined by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
2 years
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Duration of Overall Survival
Time Frame: 2 years
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Median overall survival (OS), determined by the Kaplan-Meier method.
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2 years
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Number of Participants With Toxicities According to Severity
Time Frame: 2 years
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Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm.
Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jochen Lorch, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 24, 2006
First Submitted That Met QC Criteria
October 24, 2006
First Posted (Estimate)
October 26, 2006
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
March 15, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Bevacizumab
- Sulindac
Other Study ID Numbers
- 06-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Squamous Cell Carcinoma of the Head and Neck (SCCHN)
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Eben RosenthalNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States
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Hoffmann-La RocheActive, not recruitingLocally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States, Korea, Republic of, Canada, Australia, Russian Federation, United Kingdom, Belgium, Brazil, China, France, Italy, Portugal, Spain, Japan, India, Thailand, Ukraine, Taiwan, Poland, Turkey, Hungary, South Africa, Germany
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British Columbia Cancer AgencyWithdrawnLocally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)Canada
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PfizerCompletedSquamous Cell Carcinoma of the Head and Neck (SCCHN)United States, Spain, Korea, Republic of, Czechia, Taiwan, Serbia, Japan, Slovakia, Mexico, Romania, Hungary, Italy, Poland, Russian Federation, Ukraine
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University of Michigan Rogel Cancer CenterTerminatedSquamous Cell Carcinoma of the Head and Neck (SCCHN)United States
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Glenn J. HannaSecura Bio, Inc.Active, not recruitingMetastatic Head and Neck Cancer | Advanced Head and Neck Squamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Advanced Head and Neck CancerUnited States
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Incyte CorporationActive, not recruitingAdvanced Solid Tumors | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Gastrointestinal (GI) MalignanciesUnited States, Netherlands, Spain, United Kingdom, Belgium, Austria
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PfizerEMD Serono; Astellas Pharma Inc; Nektar TherapeuticsTerminatedSquamous Cell Carcinoma of the Head and Neck (SCCHN) | Metastatic Castration Resistant Prostate Cancer (mCRPC)Spain, United States, Poland, Belgium
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AstraZenecaCompletedRecurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHNUnited States, France, Italy, Spain, Belgium, Czechia, Romania, Taiwan, Korea, Republic of, Brazil, Hungary, Japan, Russian Federation, Australia, Germany, Israel, Serbia, Bulgaria, Ukraine, Argentina, Poland, Chile, Croatia, Georgia
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Merck KGaA, Darmstadt, GermanyMerck Ltd., IndiaTerminatedUnresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck | LA SCCHNIndia
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Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
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