Status:
TERMINATED
Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Emory University
Conditions:
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ce...
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00392665
Start Date
October 1 2006
End Date
December 1 2013
Last Update
April 13 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115