This is a single arm, open-lable Phase I clinical trial. Eligible patients will have Histologically proven stage IB2-IVA cervical cancer. We hypothesize that Nab-paclitaxel in combination with cisplatin and radiotherapy may have anti-tumor activity in patients with cervical cancer. Nab-paclitaxel has not previously been combined with conventional RT-CT to treat cervical cancer.
During the phase I study, patients will receive radiation therapy to pelvis (50.4 Gy in 28fractions), and followed by HDR intracavitary (30Gy in 5 fractions) brachytherapy. Concurrent chemotherapy was administered with weekly cisplatin (40 mg/m\^2) and an escalating dose of weekly Nab-paclitaxel starting at 10 mg/m\^2 up to 70 mg/m\^2. Chemotherapy agents were administered in escalating doses to cohorts of three patients at each dose level.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Drug: Paclitaxel for Injection(Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)
Peking University 3rd Hospital
Beijing, Beijng, China
RECRUITINGMaximum Tolerated Dose(MTD)/Recommended Dose(RD)
Maximum Tolerated Dose (MTD) will be defined during the Dose Escalation Stage based on evaluation of the number of patients with Dose-limiting Toxicity (DLT). The MTD will be used to determine the Recommended Dose (RD).
Time frame: Up to 5 weeks
Number of patients with Dose Limiting Toxicity (DLT)
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions.
Time frame: Up to 5 weeks
Objective response rate (ORR)
ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR.
Time frame: Up to 5 weeks
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