Head and Neck Cancer Clinical Trial
— VECTITAXOfficial title:
"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"
Verified date | April 2019 |
Source | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 40 |
Est. completion date | September 29, 2014 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital General de Yagüe | Burgos | |
Spain | H. Virgen de las Nieves | Granada | |
Spain | Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Fundación Alcorcón | Madrid | |
Spain | Hospital de Navarra | Pamplona | Navarra |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Spain | Hospital General Universitario | Valencia | |
Spain | Hospital Universitario la Fe de Valencia | Valencia | |
Spain | Hospital Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | Amgen, Trial Form Support S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | objective response rate | To assess the effect of the combination of panitumumab and paclitaxel on objective response rate in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN). | 2 years | |
Secondary | Time to response, duration of response, progression free-survival, overall survival. | Secondary Objectives To assess the disease control rate, time to response, duration of response, progression free-survival and overall survival. To estimate changes in patient-reported outcomes (PRO). To describe the safety profile of the combination of panitumumab and paclitaxel. 1.3 Exploratory Objectives: To investigate the effects of genetic variation in cancer genes and drug target genes on subject response to panitumumab and Paclitaxel combination chemotherapy. To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints. |
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