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Randomized clinical study of SCP pacliataxel in patients with advanced cervical cancer

Abstract

Introduction: Cervical cancer is the second most commonly occurring cancer in women, and it is responsible for 15% of all female malignancies. Metastatic cervical cancer occurs in 15-61% of cases, and available oncology therapies do not offer the prospect of a cure in the majority of patients. Therefore, it is essential that other treatment modalities are developed and evaluated. Given that mandate and the excellent results that we have observed in our other SCP therapy studies, we undertook a prospective randomized clinical trial. Objective: Paclitaxel has a broad spectrum of activity against many gynecological malignancies, and oncologists commonly use it in the management of advanced or recurrent cervical cancer. Conventional paclitaxel has poor water solubility poor penetration and high side effect profile. To overcome these obstacles authors compared the use of Specific conjugate particle paclitaxel (group 1), a proven efficacious agent with advanced technical drug, and Nanoparticle Albumin-Bound Paclitaxel (NAB-Paclitaxel (Group 2) in a randomized prospective Phase III trial involving patients with advanced cervical cancer. Methods: We recruited seventy patient with persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression. Patients were randomized to receive either SCP-Paclitaxel or NAB-Paclitaxel 125 mg/m2, intravenously over 30 min on days 1, 8 and 15 of a 28-day cycle.

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