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Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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Trial Information

Randomized Study of Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

- 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

- 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of erlotinib plus bevacizumab (Arm A) or erlotinib plus sulindac (Arm B) in subjects with incurable recurrent and/or metastatic squamous cell carcinoma of the head and neck as measured by progression-free survival.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jochen Lorch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

December 2012

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • erlotinib
  • tarceva
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617