A Study of Apatinib Treatment in for Advanced Ovarian Cancer

NCT03393507 | Unknown Phase 2

• 1 other identifier: LS-OV-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer; Chemotherapeutic Toxicity

Keywords

ovarian cancer

Outcome Measures

Primary Outcomes (2)

• PFS(Progress free survival)

  he length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

  24 month

• carcinoma antigen 125 (CA125)

  Cancer antigen 125 (CA-125) is a protein found on the surface of many ovarian cancer cells. It also can be found in other cancers and in small amounts in normal tissue. A CA-125 test measures the amount of this protein in the blood.

  24month

Study Arms (2)

apatinib combine with chemotherapy

EXPERIMENTAL

Drug: Apatinib; Drug: Taxus + platinum

chemotherapy

ACTIVE COMPARATOR

Drug: Taxus + platinum

Interventions

Apatinib DRUG

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

apatinib combine with chemotherapy

Taxus + platinum 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.

apatinib combine with chemotherapy; chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: only female can be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
• Pregnant or lactating women;
• 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.

Sponsors & Collaborators

• The People's Hospital of Leshan: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Zhang xuan

Leshan, Sichuan, 600000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

apatinib; Platinum

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Xuan Zhang, MDB

CONTACT

8618990631232; 79916363@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., head of the department of the obstetrics and gynecology

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

CN (1)