Status:
COMPLETED
Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer
Lead Sponsor:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Collaborating Sponsors:
Amgen
Trial Form Support S.L.
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Car...
Detailed Description
Panitumumab, a fully human IgG2 anti-EGFR monoclonal antibody, has shown activity in preclinical models of SCCHN, and promising activity in refractory SCCHN patients in a phase I clinical trial. Recen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01264328
Start Date
March 9 2011
End Date
September 29 2014
Last Update
April 16 2019
Active Locations (12)
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1
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
2
Hospital de Navarra
Pamplona, Navarre, Spain, 31008
3
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain