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A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma
Enrollment
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Inclusion criteria
Patients who were histologically or cytologically diagnosed as having oral cavity, oropharynx, hypopharynx, or larynx squamous cell carcinoma with recurrent and metastatic evidence and who cannot be treated by salvage surgery or radiotherapy
Time of disease progression, regardless of whether that treatment or after platinum-based therapy
①Patients who have disease progression after concurrent chemoradiotherapy of curative purpose (including induction chemotherapy) including a platinum-based (cisplatin or carboplatin) chemotherapy
② Patients who have disease progression after primary or secondary treatment of palliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy
Patients who aged 20 years or older and under 79 years old
Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2
Patients who have one measurable lesion at least by RECIST criteria 1.1
Patients who show adequate function of organ:
bone marrow: Absolute Neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μ, Hb≥ 9.0 g/dl (allowed blood transfusion)
Liver: ① with no evidence of liver metastasis; Total bilirubin ≤ 1.5mg/dl, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.0 X upper limit of normal (ULN)
② with liver metastasis; bilirubin ≤ 3.0 X ULN, aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5.0 X ULN
Kidney: creatinine ≤ 1.5 X ULN
Patients who have signed written consent forms prior to participation in the clinical trial
Exclusion criteria
Patients who have Primary tumor of nasopharynx
Patients who have received treatment prior regimen of three or more drugs
Patients who have Primary malignant tumors of other sites (except if; early cervical cancer, skin basal cell cancer received appropriate treatment, Malignant tumor without recurrent state treated five years previously)
Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product
Patients who have received a major surgery within 4 weeks prior to the initial administration of the investigational product or patients who does not recover after major surgery
Patients who have severe diseases or medical condition as follows
Pregnant or lactating women
Patients considered inappropriate to participating the study by the investigator
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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