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Patients
must have histologically or cytologically confirmed Squamous Cell Cancer of
the Head and Neck (SCCHN), from any primary site, including unknown primary
cancers of the head and neck. Patient must not have nasopharyngeal carcinoma
of histologic types WHO 2 or 3 or squamous cell carcinoma that originated in
the skin.
3.2 Patients must have SCCHN
that is either (a) recurrent, judged incurable by surgery or radiation or (b)
metastatic.
NOTE: Patients who refuse radical resection for recurrent
disease are eligible
NOTE: A second primary squamous cell carcinoma of the head
and neck is allowed if eligibility is based on a recurrent or metastatic
first primary squamous cell carcinoma of the head and neck.
3.3 No prior chemotherapy or
biologic/molecular targeted therapy for recurrent or metastatic SCCHN.
3.3.1
Patients may have received one regimen of induction, concomitant
chemoradiotherapy and/or adjuvant chemotherapy as part of initial potential
curative therapy but must not have received prior chemotherapy for
recurrent or metastatic disease.
3.3.2
A minimum of 4 months is required between last dose of chemotherapy or
chemoradiotherapy and study treatment. In addition patients must be
progression-free for at least 4 months after completion of chemotherapy or
chemoradiotherapy or radiation plus cetuximab given with a curative intent.
(Cetuximab therapy: 4 months is required between last dose of chemotherapy or
chemoradiotherapy and study treatment if part of concurrent regimen, 8 weeks
if part of adjuvant regimen post radiation).
3.3.3 Patients having
progression after 2 cycles of induction chemotherapy are not eligible for the
study.
3.4 No prior bevacizumab is allowed
A
maximum of one prior radiotherapy regimen, curative or palliative, to the
head and neck is allowed. If the radiation is combined with chemotherapy
and/or cetuximab, a minimum of 4 months must elapse between the end of
radiotherapy and registration. If the radiation is given alone, a minimum of
8 weeks must elapse between the end of radiotherapy and registration. A
minimum of 3 weeks must elapse between prior radiation to other areas and
registration.
3.6 Patients must not be
receiving any other investigational agent while on the study.
ECOG
performance status of 0-1
3.8
Patients must have recovered to grade 1 or better from any acute effects of
prior surgery, chemotherapy, or radiation therapy, and should be > 4 weeks
post surgery. Chronic late xerostomia, speech and swallowing abnormalities
resulting from prior radiation or surgery are permitted if nutritional status
is stable.
3.9 Patients must have
measurable disease based on RECIST (see Sec. 6.0). Baseline measurements and
evaluations of all sites of disease must be obtained < 4 weeks prior to
randomization. Disease in previously irradiated sites is considered
measurable if there has been unequivocal disease progression or biopsy-proven
residual carcinoma following radiation therapy.
Persistent disease after
radiotherapy must be biopsy proven at least 8 weeks after completion of
radiation therapy. (Radiographic findings are acceptable providing that
clear-cut measurements can be made).
ANC> 1500
Hgb > 8.0
Plt >100k
Creatinine C >60
No
known brain metastases.
3.14 Patients who meet the
following criteria will be excluded due to the possibility of increased risk
for tumor bleeding with bevacizumab therapy:
3 history of gross hemoptysis
(bright red blood of ½ teaspoon or more per episode of coughing) < 3
months prior to enrollment.
3.15
No history of coagulopathy or hemorrhagic disorders.
3.16
Patients should not have a history of thrombosis (e.g. pulmonary embolism or
deep venous thrombosis) currently requiring therapeutic anticoagulation
(prophylactic use of warfarin 1 mg per day is allowed) and INR should be <
1.5 at registration.
3.17
Patients must not be receiving chronic daily treatment with aspirin (> 325
mg/day) or non-steroidal anti-inflammatory agents (NSAID’s) known to inhibit
platelet function. 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.
3.18
No hypercalcemia related to head and neck cancer.
3.19
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.
3.20
No current peripheral neuropathy > grade 2 at time of randomization.
3.21
Patients must not have any co-existing condition that would preclude full
compliance with the study.
3.22
No prior history of severe hypersensitivity reaction to Docetaxel or other
drugs formulated with polysorbate 80, if the physician’s choice of
chemotherapy regimen is docetaxel.
3.23 All patients must have
blood pressure < 150/90 < 2 weeks prior to randomization. Patients with
history of hypertension must be well controlled (<150/90) on stable
anti-hypertensive therapy
No major surgical procedure,
open bx or significant traumatic injury less than 28 days prior to study
enrollment (or anticipation of needing such during the course of the study)
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