NCT04661696

Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in Ovarian Cancer.

Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer: a Multicenter, Open, Phase 2 Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.

Detailed description

This study is a multicenter, open, single arm, phase 2 clinical study in patients with platinum-sensitive recurrent ovarian cancer.75 patients were planned to be enrolled, and the eligible patients were given the following regimen: Paclitaxel (Albumin-Bound) 130 mg/m\^2, i.v., d1, d8;Carboplatin AUC 5, i.v.,d1;Every 21 days is a cycle, a total of 6 cycles.This study will be divided into three stages.The baseline period:Patients will complete screening tests at baseline to assess eligibility for inclusion criteria.Treatment period:(from the first dose to the last treatment cycle).Imaging tumor assessment was performed every 2 cycles (i.e. 6 weeks).Follow-up period:At the end of the study, patients were followed up by telephone or at the study center every 3 months to collect survival status and subsequent antitumor treatment until death or loss of follow-up.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel (albumin-bound)	The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed. Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage.

Timeline

• Start date: 2020-12-09
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2020-12-10
• Last updated: 2020-12-10

Locations

1 site across 1 country: China