A Prospective, open label, non randomized, comparative pharmacokinetic study of Paclitaxel pharmacokinetics in women with different Body Mass Index undergoing chemotherapy for breast and ovarian cancer. - Paclitaxel PK Study

Tata Memorial Hospital0 个研究点目标入组 36 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。

•1.Female patient >= 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 malignancy of the Breast or Ovary.
•5.Treatment planned with Paclitaxel at a dose of 175mg/m2 to be administered over 3 hours.
•6.Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
•7.Adequate hematologic function (ANC ï?³ 1500 cells/ÂµL: Hemoglobin ï?³ 9 gm/dl, Platelets ï?³ 1.0 lakh/mm3).
•8.Adequate renal function (Serum creatinine ï?£ 1.5 x ULN, if creatinine more than 1.0 x ULN and less or equal to 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be equal or more than 40 ml/min).
•9.Serum bilirubin ï?£ 1.0 x ULN, ALT ï?£ 2.5 x ULN, AST ï?£ 2.5 x ULN). If liver metastasis is present ALT ï?£ 5 x ULN, AST ï?£ 5 x ULN.
•10.Female patients must have a negative serum pregnancy test at baseline (not applicable to patients with bilateral oophrectomy and/ or hysterectomy or to those patients who are > 1 year postmenopausal).
•11.All patients of reproductive age group must agree to use of an approved form of contraception.
•12.Should have completed at least 3 weeks from last chemotherapy.
•13.Should have completed at least 6 weeks from last radiotherapy.
•14.Previous radiotherapy site should have included <25% of the total bone marrow.

•1.Known allergy to taxanes.
•2.Grade 2 or higher peripheral neuropathy (e.g. numbness, tingling and/or pain in distal extremities.
•3.Symptomatic or clinically active CNS disease or metastatic lesions (prior radiotherapy to brain metastases is allowed).
•4.Major surgery within last 4 weeks and end of prior radiotherapy within last 6 weeks.
•5.Pregnant or breast feeding women.
•6.Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease).
•7.Any history of angina pectoris, coronary artery disease or cerebrovascular disease or transient ischemic attack.
•8.Cardiac arrhythmia requiring medical therapy.
•9.Known chronic infection with HIV, Hepatitis B and C.
•10.Patients unwilling to comply with the study procedures.
•11.Prior radiotherapy involving the entire pelvis.
•12.Presence of third space fluid (ascitis or pleural effusion) which cannot be removed completely before the study drug administration.

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