VMAT Concurrent Cisplatin Plus Nab-paclitaxel for Local Advanced Cervical Cancer

NCT ID: NCT04017377

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-07-15

Brief Summary

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.

Detailed Description

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.

Conditions

Cervical Cancer

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy+ Radiation therapy

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.

Group Type: EXPERIMENTAL

Drug: Cisplatin; nab-paclitaxel

Intervention Type: DRUG

Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)

Interventions

Drug: Cisplatin; nab-paclitaxel

Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and ≤ 75 years.
• Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): Federation of Gynecology and Obstetrics (FIGO) clinical stages IB2-IVA.
• At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• The expected survival after surgery ≥ 3 months;
• LVEF≥55%;
• Bone marrow function: Neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, and hemoglobin ≥ 90 g/L;
• Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
• Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age;
• Women must not lactate;
• Signed informed content obtained prior to treatment；

Exclusion Criteria

• Patients previously treated with nab-paclitaxel;
• Patients previously undergoing abdominal or pelvic radiotherapy；
• Patients with CNS diseases or brain metastases；
• Other malignant tumors other than cervical cancer occurred in the past 5 years；
• Patients who had Grade 2 or above Peripheral neuropathy；
• Patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc；
• Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires；
• History of allergy or hypersensitivity to any therapeutic ingredient；
• Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection；
• Previously received systemic therapy for advanced/metastatic pancreatic cancer;
• Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen；
• Patients who had Grade 2 or above Peripheral neuropathy；
• Known to be allergic, highly sensitive or intolerant to the study-related drugs or their excipients;
• Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period；
• Severe infections including, but not limited to, complications of infection, bacteremia or severe pneumonia that require hospitalization within 4 weeks of study treatment initiation；
• Subjects had hepatitis b surface antigen (HBsAg)-positive and HBV- DNA titer in peripheral blood greater than or equal to 1000 copy number /L; If HBsAg is positive and the peripheral blood HBV-DNA <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects；
• Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients；
• The researchers considered that there were other conditions that were not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junjie Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junjie Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University 3rd Hospital

Beijing, Beijng, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junjie Wang, MD, PhD

Role: CONTACT

junjiewang_edu@sina.cn

13701076310

Ping Jiang, MD

Role: CONTACT

jp7962@sohu.com

13439796018

Facility Contacts

Junjie Wang, MD

Role: primary

junjiewang_edu@sina.cn

010-82266699 ext. 5920

Other Identifiers

M2019163

Identifier Type: -

Identifier Source: org_study_id