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

NCT04017377 | Unknown

• 1 other identifier: M2019163
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of patients with Dose Limiting Toxicity (DLT)

  Up to 5 weeks

• Objective response rate (ORR)

  Up to 5 weeks

Study Arms (1)

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.

Drug: Drug: Cisplatin; nab-paclitaxel

Interventions

Drug: Cisplatin; nab-paclitaxel DRUG

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

Chemotherapy+ Radiation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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；

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijng, 100191, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Junjie Wang, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junjie Wang, MD, PhD

CONTACT

13701076310; junjiewang_edu@sina.cn

Ping Jiang, MD

CONTACT

13439796018; jp7962@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: September 1, 2019
• Primary Completion: June 15, 2020
• Study Completion: July 15, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)