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Therapeutic Areas: Oncology
Disease Category: Head and Neck Cancer

Trial Information

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, 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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) from any primary site
• 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
• 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 (i.e., tumor crosses fat boundary)
• 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
  • 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 prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • 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 significant traumatic injury within the past 28 days
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
  • 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

  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 6 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

  Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
  Memorial Health University Medical Center
  William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
  4700 Waters Avenue
  Savannah, GA 31404
  Phone: 912 350-7887
  Fax: 912 350-8183
  EMail: sharppa1@memorialhealth.com

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  Research Center Information: Memorial Health University Medical Center

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