Clinical trial NCT01264328 (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: panitumumab + paclitaxel
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Signed Inform Consent

          -  Age > 18 years

          -  Histologically or cytologically confirmed SCCHN

          -  Diagnosis of metastatic disease by the investigator and/or recurrent disease
             determined to be incurable by surgery or radiotherapy

          -  Subjects who have received radiation as primary therapy are eligible if radiation
             therapy treatment was completed > 4 weeks prior to inclusion

          -  Subjects who have previously received chemotherapy as part of the initial
             multimodality treatment for locally advanced disease are eligible if the chemotherapy
             was completed > 24 weeks prior to inclusion

          -  At least 1 unidimensionally measurable lesion of ≥ 20 mm using conventional techniques
             or ≥10 mm with spiral CT scan. Target lesions must not be chosen from a previously
             irradiated field unless there had been documented tumour progression in that lesion
             prior to inclusion

          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening

          -  Haematological function:

               -  ANC ≥ 1.5 x 109 cells/L

               -  Hemoglobin ≥ 9.0 g/dL

               -  Platelet count ≥ 100 x 109/L

          -  Kidney function:

             o Adequate renal function with creatinine clearance ≥ 60 mL/min)

          -  Liver function:

               -  AST ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)

               -  ALT ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)

               -  Bilirubin ≤ 2 x ULN

          -  Metabolic function:

               -  Magnesium ≥ lower limit of normal,

               -  Calcium ≥ lower limit of normal

        Exclusion Criteria:

          -  Documented or symptomatic central nervous system metastases

          -  Nasopharyngeal carcinoma

          -  History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
             evidence of interstitial lung disease on baseline chest scan

          -  History of another primary cancer, except:

               -  Curatively treated in situ cervical cancer, or

               -  Curatively resected non-melanoma skin cancer or

               -  Other primary solid tumour curatively treated with no known active disease
                  present and no treatment administered for ≥ 3 years prior to starting the study
                  treatment. In that case confirmation of inclusion by the sponsor is required.

          -  Clinically significant cardiovascular disease ≤ 1 year prior to starting the study
             treatment

          -  Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
             8 weeks prior to starting the study treatment

          -  Symptomatic peripheral neuropathy of Grade ≥ 2 based on the CTCAE v3.0

          -  Subjects not recovered from all previous acute radiotherapy-related toxicities to ≤
             grade 1

          -  History of severe skin disorder that in the opinion of the investigator may interfere
             with study conduct

          -  Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
             virus, acute or chronic hepatitis B infection

          -  Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days
             prior to starting the study treatment

          -  History of interstitial pneumonia or pulmonary fibrosis or signs of interstitial
             pneumonia or pulmonary fibrosis on the baseline chest X-ray.

          -  Known allergy or hypersensitivity to panitumumab, or other study medications.

          -  Prior anti epidermal growth factor receptor (EGFr) antibody therapy or treatment with
             small molecule EGFr inhibitors unless received as part of prior multimodality
             treatment and completed > 24 weeks prior to starting the study treatment. In this
             case, the investigator should confirm that the subject had not presented any previous
             cetuximab-related infusion reaction > grade 2.

          -  Subject is currently enrolled in or ≤ 30 days since ending other investigational
             device, investigational procedure, or drug study(s), or subject is receiving other
             investigational agent(s)

          -  Subjects requiring use of immunosuppressive agents, however, corticosteroids are
             allowed

          -  Man or woman of child-bearing potential who do not consent to use adequate
             contraceptive precautions during the course of the study, and for 6 months after the
             last study drug administration for women, and 3 months for men.

          -  Female subject who is pregnant or breast-feeding, or planning to become pregnant
             within 6 months after the end of treatment.

          -  Major surgery requiring general anesthesia/ spinal anesthesia and a significant
             incision ≤ 28 days or minor surgery ≤ 14 days prior to starting the study treatment.
             Subjects must have recovered from surgery-related toxicities.

          -  Subjects who do not wish to meet the study requirements or are unable to do so.