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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+ Radiation therapy | Experimental | Chemotherapy: Patients firstly receive an escalating dose of weekly Nab-paclitaxel starting at 10 mg/m^2 up to 70 mg/m^2, Patients secondly receive weekly cisplatin (40 mg/m^2). Treatment repeats every week until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. Concurrent chemotherapy is a weekly regimen during radiotherapy. Patients will complete at least 4 cycles of concurrent chemoradiotherapy, until the maximal tolerated dose (MTD) appeared. Radiation therapy: Patients also receive pelvic radiation therapy once daily (Monday-Friday) for a total of 28 fractions and intracavitary brachytherapy twice a week for a total 5 fractions. Complete radiotherapy within 55 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Cisplatin; nab-paclitaxel | Drug | Drug: Paclitaxel for Injection(Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum 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). | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 weeks |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Wang, MD, PhD | Contact | 13701076310 | junjiewang_edu@sina.cn | |
| Ping Jiang, MD | Contact | 13439796018 | jp7962@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, MD, PhD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Recruiting | Beijing | Beijng | 100191 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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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.
| Up to 5 weeks |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |