Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer

• Status: Completed
• Trial end date: 2014-09-29
• Target enrollment: 0
• Participant gender: All

Summary

The clinical hypothesis of this study is that the first-line treatment with the combination of panitumumab and paclitaxel will provide benefit for patients with metastatic or current Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
• Collaborators: Amgen; Trial Form Support S.L.
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Paclitaxel; Panitumumab

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.