Clinical trial NCT00203905 (phase 2, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: 5-fluorouracil, hydroxyurea-[fhx], bevacizumab, 5-fluorouracil, hydroxyurea-[fhx]
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have stage II-III (carcinoma of head and neck, including oral cavity,
             pharynx, larynx, paranasal sinuses and cervical esophagus). Selected patients with
             stage disease (T will also be considered for enrolment). Therapy is given with
             curative intent. Patients with clinical N2 or N3 disease are excluded.

          -  Prior to entry in the study the resectability and standard treatment options for each
             patient will be determined during a joint evaluation by a team composed of an
             attending surgeon, a radiation oncologist and a medical oncologist. In addition the
             timing and feasibility of initial organ preserving surgery will be determined in each
             patient prior to therapy at the discretion of the treating surgeon. Salvage surgery
             and neck dissection will be allowed for suspicious or evident residual disease at the
             completion of the treatment regimen.

          -  Measurable disease is not required.

          -  Patients must have a histologically or cytologically confirmed diagnosis of carcinoma
             of the head and neck.

          -  No prior exposure to chemotherapy or radiotherapy for a malignancy of the head and
             neck.

          -  Patients must have ECOG performance status of 0-2.

          -  Age 18 years of age and older.

          -  Patients must have normal organ and bone marrow function.

        Exclusion Criteria:

          -  Receiving any other investigational agents

          -  Recent (within 6 months) myocardial infarction, New York Heart Association (NYHA) -
             Class H or greater congestive heart failure, serious cardiac arrhythmia requiring
             medication, or Grade II or greater peripheral vascular disease within 1 year prior to
             treatment in the study

          -  Serious, non-healing wound, ulcer, or bone fracture.

          -  History of recurrent or chronic deep vein thrombosis or pulmonary embolus

          -  History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic
             or thrombotic stroke within the last 6 months

          -  Uncontrolled hypertension

          -  Evidence of bleeding diathesis or coagulopathy

          -  History of hemoptysis

          -  Anatomic lesion that increases the risk of serious hemorrhage (e.g. invasion of a
             major vessel by tumor).

          -  History of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that might affect the
             interpretation of the results of the study or render the subject at high risk from
             treatment complications.

          -  Current ongoing treatment with any dose of warfarin or its equivalent.

          -  Major surgical procedure or significant traumatic injury within 28 days prior to Day
             0.

          -  Fine needle aspirations, indwelling catheter placement, or significant traumatic
             injury within 7 days prior to Day 0

          -  Anticipation of need for major surgical procedure during the course of the study.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to rhuMAb VEUF or other agents used in the study.

          -  History of a concurrent malignancy or a history of a prior malignancy within the past
             3 years.

          -  Pregnant women

          -  HIV-positive patients receiving combination anti-retroviral therapy