A phase II controlled clinical trial comparing efficacy of Cabazitaxel versus Docetaxel in recurrent head and neck cancer in India

Tata Memorial Hospital0 个研究点目标入组 92 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Inclusion Criteria:
•1.Male or female patient, greater than or equal to 18 years of age.
•2.Written informed consent must be obtained prior to any study related procedures.
•3.Life expectancy of at least 3 months.
•4.Histologically or cytologically confirmed squamous cell carcinoma of head and neck cancer excluding salivary gland.
•5.Measurable disease on cross sectional imaging that is at least 2 cm in longest diameter (1 cm if measured by spiral CT).
•6.Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
•7.Adequate bone marrow, liver, and renal function: Neutrophils >= 1500 /mm3; Hemoglobin >= 8.5 g/dL; Platelets >= 100 x109/L; Bilirubin <= ULN; SGOT (AST) <= 2.5 x ULN; SGPT (ALT) <= 2.5 x ULN; Creatinine <= 1.5 x ULN. In case of creatinine > 1.0 x ULN and <= 1.5 x ULN creatinine clearance should be >= 60 ml/min according to CKD-EPI formula.
•8.Female patients must have a negative blood pregnancy test at baseline (not applicable to patients who have had bilateral oophrectomy and/ or hysterectomy or to those patients who are > 1 year postmenopausal).
•9.All patients of reproductive age group must agree to use of an approved form of contraception.
•10.Should have failed at least one line of therapy (excluding taxanes) for locally advanced or metastatic head and neck cancer. Adjuvant chemotherapy with relapse within 6 months after end of adjuvant therapy will be considered as first line of therapy.

•Exclusion Criteria:
•1.No prior taxanes.
•2.Known allergy to taxanes.
•3.Prior hypersensitivity to polysorbate 80.
•4.Grade 2 or higher peripheral neuropathy (e.g. Numbness, tingling and/or pain in distal extremities.
•5.Symptomatic or clinically active CNS disease or metastatic lesions (prior radiotherapy to brain metastases is allowed).
•6.Major surgery within last 4 weeks and end of prior radiotherapy within last 6 weeks.
•7.Pregnant or breast feeding women.
•8.Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease).
•9.Any uncontrolled coronary artery disease or cerebrovascular disease or transient ischemic attack.
•10.Cardiac arrhythmia requiring medical therapy.
•11.Known infection with HIV or active infection with Hepatitis B and C.
•12.Patients unwilling to comply with the study procedures.

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