Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer

Ovarian Cancer Clinical Trial

— OC-01  

Official title:

Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03818282
• Other study ID #: 2019-GYN/OC-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2019
• Source: Huazhong University of Science and Technology
• Contact: Ding Ma, M.D.
• Phone: 02783663351
• Email: dma[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 77
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18 to 75 years;

• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;

• Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;

• Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;

• ECOG performance status of 0-2;

• Expected survival = 3 months;

• Bone marrow function: Neutrophils = 1.5×109/L, platelets = 100×109/L, hemoglobin = 90 g/L;

• Hepatic and renal function: Serum creatinine = 1.5×ULN; AST and ALT = 1.5×ULN or = 5×ULN in the presence of hepatic metastasis; Total bilirubin = 1.5×ULN, or = 2.5×ULN in patients with Gilbert's syndrome;

• Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.

Exclusion Criteria:

• Ovarian low-grade malignant tumor patients;

• Patients who have received abdominal or pelvic radiotherapy;

• Patients with central nervous system disease or brain metastases;

• Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;

• Prior Grade = 2 sensory or motor neuropathy;

• Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;

• Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;

• Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;

• Patients not suitable for participation in this study judged by investigator.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paclitaxel for injection (albumin-bound)
Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free Survival	PFS	2 year