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Pilot Study of Induction Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A) in Patients With Locally Advanced Head and Neck Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Neoplasms

Thank you

Trial Information

Pilot Study of Induction Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A) in Patients With Locally Advanced Head and Neck Cancer

Inclusion Criteria:

- Patients with AJCC 6th edition stage III-IVB head and neck cancer, all sites,
including unknown primary tumors.

- Prior to entry in the study the resectability and alternative treatment options for
each patient will be determined by a team composed of an Ear, Nose, and Throat
Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination,
optimal local treatment, and its timing according to this protocol will be determined
at this evaluation. The unequivocal demonstration of distant metastasis (M1) confers

- Histologically or cytologically confirmed diagnosis of squamous cell or poorly
differentiated carcinomas, or WHO types I-III of the nasopharynx.

- Unidimensionally measurable disease is required (RECIST 1.1).

- No prior chemotherapy, biologic/molecular targeted therapy (including any prior
therapy which specifically and directly targets the EGFR pathway), or radiotherapy
for head and neck cancer.

- Prior surgical therapy will consist only of incisional or excisional biopsy, and
organ sparing procedures such as debulking of airway compromising tumors or neck
dissection in a patient with an existing primary tumor. Any non-biopsy procedure must
have taken place > 4 weeks but < 3 months of initiating protocol treatment.

- ECOG performance status 0-1.

- Age of at least 18 years.

- Informed consent must be obtained from all patients prior to beginning therapy.
Patients should have the ability to understand and the willingness to sign a written
informed consent document.

- All patients should have their tumor tissue tested for HPV and will consent to have
available archival tumor samples, unstained slides or blocks from previous diagnostic
or therapeutic procedures submitted for correlative studies, including assessment of
target molecules EGFR, VEGF and related biomarkers. Also, patients must agree to
submit blood samples for correlative studies at least at baseline.

- Absolute neutrophil count equal to or greater than 1500/µl, Platelet count equal to
or greater than 100,000/µl

- Creatinine clearance 60 ml/min or higher calculated using the Cockcroft-Gault

Calculated Creatinine Clearance = (140-age) X actual body wt.(kg) 72 X serum creatinine
Multiply this number by 0.85 if the patient is female

- Total bilirubin within normal limits and AST/ALT less than 3 times the upper limit of

- Urine to protein to creatinine (UPC) ratio should be <1.0 at screening

NOTE: UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC
ratio of 1 is roughly equivalent to a 24-hour urine protein of 1gm. UPC ratio is
calculated using one of the following formula:

- [urine protein]/[urine creatinine] - if both protein and creatinine are reported in

- [(urine protein) × 0.088]/[urine creatinine] - if urine creatinine is reported in

- Patients with a prior history of squamous cell or basal carcinoma of the skin or
in situ cervical cancer must have been curatively treated. Patients with a
history of other prior malignancy must have been treated with curative intent
and must have remained disease-free for 3 years post diagnosis.

- Patients may not be receiving any other investigational agents.

Exclusion Criteria:

- History of severe allergic reactions attributed to docetaxel or compounds of similar
chemical or biologic composition to docetaxel, or other drugs formulated with
polysorbate 80.

- Prior severe infusion reaction to a monoclonal antibody or known hypersensitivity to
any component of bevacizumab

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.

- All patients will have a baseline EKG. If abnormalities consistent with active
coronary artery disease are detected, the patient will be referred to a cardiologist
for appropriate evaluation and management prior to treatment on study

- No patients with significant baseline sensory or motor neurologic deficits (> grade I
neuropathy) will be treated on this study.

- Because patients with immune deficiency are at increased risk of lethal Infections
when treated with marrow-suppressive therapy, HIV-positive patients are excluded from
the study. Appropriate studies will be undertaken in patients with HIV and those
receiving combination anti- retroviral therapies when indicated.

- Patients with HPV positive tumors

- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg
and/or diastolic blood pressure > 100 mmHg)

- Prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
Appendix F)

- History of myocardial infarction or unstable angina within 12 months prior to Day 1

- No history of stroke or transient ischemic attack within 6 months prior to Day 1

- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1

- History of hemoptysis (equal to or greater than 1/2 teaspoon of bright red blood per
episode) within 1 month prior to Day 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- Patients should not be on therapeutic anticoagulation therapy (prophylactic use of
warfarin 1mg per day is allowed) and INR should be <1.5 at registration

- The use of anti-platelet agents (e.g. dipyridamole (Persatine), ticlopidine (Ticlid),
clopidogrel (Plavix)) is allowed only if patient is not receiving aspirin or NSAID's
known to inhibit platelet function.

- 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

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Pregnant or breast-feeding women will be excluded.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

To evaluate the rate of complete responses with induction with cisplatin, docetaxel, cetuximab and bevacizumab (TPE-A) in patients with locally advanced head and neck cancer.

Outcome Time Frame:

10 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms



Hillman Cancer Center Pittsburg, Pennsylvania  15232