A Study of Apatinib Treatment in for Advanced Ovarian Cancer

NCT ID: NCT03393507

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-01

Brief Summary

The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the advanced ovarian cancer

Detailed Description

Ovarian cancer and fallopian tube cancer are common gynecological malignancies in our country. Ovarian cancer ranks the second in the incidence of gynecologic malignancies. The mortality rate is the highest. The following three major characteristics exist: First, 70% of the patients are advanced patients; 70% of the patients Easy to relapse after treatment; Third, 5-year survival rate of about 30%, a serious threat to women's health. Our hospital ovarian cancer, tubal cancer patients because of regional constraints, the economy is poor, the more the past, the use of simple chemotherapy, relapse rate and mortality were higher.

In the latest National Comprehensive Cancer Network (NCCN) guidelines, bevacizumab plus CP is recommended for patients with stage II, III, and IV ovarian cancer and fallopian tube cancer, and clinical trials of new drugs are recommended for recurrent / metastatic ovarian cancer. Apatinib mesylate is a small molecule VEGFR tyrosine kinase inhibitor authored by Jiangsu Hengrui Pharmaceutical Co., Ltd., whose chemical name is N- [4- (Cyanocyclopentyl) phenylmethane sulfonate ] [2 - [(4-picolyl) amino] (3-pyridyl)] carboxamide of the formula C25H27N5O3S with a molecular weight of 493.58 (mesylate salt).Apatinib can effectively inhibit VEGFR-2 at a very low concentration, while higher concentrations can inhibit the action of apatinib, such as platelet-derived growth factor receptor (PDGFR), c-Kit and c- The site is the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamic studies show that apatinib can inhibit the VEGFR-2 tyrosine kinase activity, blocking VEGF signaling after binding, resulting in inhibition of tumor angiogenesis. Preclinical studies have shown that apatinib has a strong inhibitory effect on the growth of many human nude mice xenografts such as sarcoma, colorectal cancer, non-small cell lung cancer, gastric cancer and liver cancer and is a broad-spectrum anti-tumor drug.

Conditions

Ovarian Cancer; Chemotherapeutic Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib combine with chemotherapy

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles

Taxus + platinum

Intervention Type: DRUG

Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time\> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.

chemotherapy

Group Type: ACTIVE_COMPARATOR

Taxus + platinum

Intervention Type: DRUG

Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time\> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.

Interventions

Apatinib

500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles

Intervention Type: DRUG

Taxus + platinum

Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time\> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pathologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, stage II-IV period, the expected survival of> 6 months;
• ECOG <2;
• Liver and kidney function is normal;
• No uncontrollable high blood pressure, bleeding, perforation, obstruction.

Exclusion Criteria

• Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
• Pregnant or lactating women;
• 3 years have occurred in other tumors (cervical cancer in situ, has cured basal cell carcinoma, except for bladder epithelial tumors);
• Allergic to apatinib or its accessories.

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

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The People's Hospital of Leshan

OTHER

Sponsor Role: lead

Responsible Party

Zhang Xuan

M.D., head of the department of the obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhang xuan

Leshan, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuan Zhang, MDB

Role: CONTACT

79916363@qq.com

8618990631232

Facility Contacts

Zhang Xuan, MD

Role: primary

79916363@qq.com

861890631232

Other Identifiers

LS-OV-2018

Identifier Type: -

Identifier Source: org_study_id