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A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab In Patients With Recurrent Or Metastatic Head and Neck Cancer

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Trial Conditions
  • Head and Neck Cancer
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IVA Salivary Gland Cancer
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Salivary Gland Cancer
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Salivary Gland Cancer
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works with or without bevacizumab in treating patients with recurrent or metastatic head and neck cancer.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck (SCCHN) from any primary site, including unknown primary cancers of the head and
neck

- No nasopharyngeal carcinoma of histologic types WHO 2 or 3

- No squamous cell carcinoma that originated in the skin

- Recurrent disease, incurable disease as determined by surgery or radiation, or
metastatic disease

- A second primary squamous cell carcinoma of the head and neck allowed if
eligibility is based on a recurrent or metastatic first primary squamous cell
carcinoma of the head and neck

- Patients who refuse radical resection for recurrent disease are eligible

- Patients must have measurable disease based on RECIST

- Disease in previously irradiated sites is considered measurable if there has
been unequivocal disease progression or biopsy-proven residual carcinoma after
radiotherapy

- Persistent disease after radiotherapy must be biopsy proven at least 8 weeks
after completion of radiotherapy (radiographic findings are acceptable providing
that clearcut measurements can be made)

- Patients must be progression-free for at least 6 months after completion of
chemotherapy or chemoradiotherapy or radiotherapy plus cetuximab given as part of
initial potential curative therapy (if received such prior therapy)

- At least 6 months since completion of prior concurrent radiotherapy plus
cetuximab (8 weeks for cetuximab given as part of adjuvant regimen post
radiotherapy)

- Patients having progression after 2 courses of induction chemotherapy are not
eligible

- No tumors that invade major vessels (e.g., the carotid) as shown unequivocally by
imaging studies

- No central (i.e., within 2 cm from the hilum) lung metastases that are cavitary as
shown unequivocally by imaging studies

- No known brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- ANC ≥ 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm^3

- Creatinine clearance ≥ 60 mL/min

- Total bilirubin normal

- AST or ALT and alkaline phosphatase must meet one of the following criteria:

- Alkaline phosphatase normal AND AST or ALT ≤ 5 x upper limit of normal (ULN)

- Alkaline phosphatase > 1 but ≤ 2.5 x ULN AND AST or ALT > 1 but ≤ 1.5 x ULN

- Alkaline phosphatase > 2.5 but ≤ 5 x ULN AND AST or ALT normal

- Urine dipstick must be < 0-1+ within 2 weeks of randomization OR urine
protein:creatinine ratio < 1 OR 24-hour urine protein < 1 g

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients who meet the following criteria are excluded:

- Any prior history of bleeding related to the current head and neck cancer

- History of gross hemoptysis (bright red blood of ½ teaspoon or more per episode
of coughing) ≤ 3 months prior to enrollment

- No history of coagulopathy or hemorrhagic disorders

- No history of thrombosis (e.g., pulmonary embolism or deep venous thrombosis)
currently requiring therapeutic anticoagulation (prophylactic use of warfarin 1
mg/day is allowed)

- INR < 1.5 at registration

- No hypercalcemia related to head and neck cancer

- Patients with a prior history of squamous cell or basal cell carcinoma of the skin or
in situ carcinoma of the cervix 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 5 years post diagnosis

- No current peripheral neuropathy ≥ grade 2

- Patients must not have any co-existing condition that would preclude full compliance
with the study

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80 (if the physician's choice of chemotherapy is docetaxel)

- Patients must have a blood pressure (BP) ≤ 150/90 within 2 weeks prior to
randomization

- Patients with a history of hypertension must be well-controlled upon study entry
(BP ≤ 150/90 mm Hg) on a stable regimen of anti-hypertensive therapy

- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to registration

- No significant traumatic injury within the past 28 days

- No serious nonhealing wound, ulcer, or bone fracture

- No unstable angina or myocardial infarction within the past 6 months

- No symptomatic congestive heart failure or New York Heart Association (NYHA) class
II-IV heart disease

- No history of aortic dissection or presence of aneurysm > 6 cm (or at high risk for
rupture)

- No serious cardiac arrhythmia requiring medication (history of chronic atrial
fibrillation or other atrial arrhythmia with controlled rate on medication is
allowed)

- No clinically significant peripheral vascular disease manifested by intermittent
claudication or need for vascular intervention

- No history of any CNS cerebrovascular ischemia or stroke within the past 6 months

- No active serious infection

- No history of a serious human anti-human antibody (HAHA) reaction

- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human antibodies are not eligible

- Chronic late xerostomia, speech and swallowing abnormalities, resulting from prior
radiation or surgery, allowed provided nutritional status is stable

- No other prior malignancy except curatively treated squamous cell or basal carcinoma
of the skin, in situ cervical cancer, or malignancy for which the patient has been
curatively treated and remains disease-free for the past 3 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Patients must have recovered to grade 1 or better from the effects of any prior
surgery, chemotherapy, or radiotherapy AND > 4 weeks post-surgery

- No more than one prior radiotherapy regimen, curative or palliative, to the head and
neck allowed

- At least 4 months since prior radiotherapy in combination with chemotherapy
and/or cetuximab

- At least 8 weeks since prior radiotherapy given alone

- At least 3 weeks since prior radiotherapy to other areas

- No prior bevacizumab

- No prior chemotherapy or biologic/molecular-targeted therapy for recurrent or
metastatic SCCHN

- Patients may have received one regimen of induction, concurrent
chemoradiotherapy, and/or adjuvant chemotherapy as part of initial potential
curative therapy

- A minimum of 6 months is required between last dose of chemotherapy or
chemoradiotherapy and study treatment

- No major surgical procedure or open biopsy within 28 days prior to study enrollment,
or anticipation of need for major surgical procedure during the course of the study

- More than 4 weeks since prior surgery

- No other concurrent investigational agent

- Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or
nonsteroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function

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

- No HIV-positive patients on combination antiretroviral therapy

- No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy
(excluding contraceptives and replacement steroids), radiotherapy, or experimental
medications

- No concurrent amifostine

- No concurrent bisphosphonates for bone metastasis unless initiated > 3 months before
study entry

Gender: Both
Steward Physician(s)
  • Athanassios (Ethan) Argiris
  • Panos Savvides, MD
Facilities
  • Holy Family Hospital - Recruiting
Trial Interventions
Biological
  • bevacizumab
Drug
  • docetaxel
  • cisplatin
  • carboplatin
  • fluorouracil
Other
  • laboratory biomarker analysis
  • cytology specimen collection procedure
For more information about this trial, contact

Han-Ting Lin

Phone: (978) 687-0151


Physician Researcher

Investigator Name:

  • Athanassios (Ethan) Argiris
  • Panos Savvides, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT00588770
Volunteers:  Not Accepting Healthy Volunteers

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