Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

NCT ID: NCT03942068

Last Updated: 2019-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-30

Brief Summary

The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.

Detailed Description

The study is an open, one-arm, prospec will collect 35 patients with platinum-resistant recurrent ovarian cancer treated with apatinib with albumin-bound paclitaxel from 2019 to 2020 in Henan Cancer Hospital.Antiangiogenic treatments have been implicated to play a major role in ovarian cancer (OC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), in combination with weekly paclitaxel, may improve clinical outcomes compared with apatinib or paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

albumin-bound paclitaxel+apatinib

albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po

Group Type: EXPERIMENTAL

albumin-bound paclitaxel

Intervention Type: DRUG

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor

Apatinib

Intervention Type: DRUG

a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)

Interventions

albumin-bound paclitaxel

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor

Intervention Type: DRUG

Apatinib

a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female, age ≥18 years and ≤70 years, signed informed consent.

2. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy).

3. At least treated with one line of platinum-based chemotherapy.

4. Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.

5. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.

6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.

7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

8. Patients must have a life expectancy of at least 3 months.

9. Patients must have adequate organ function as defined by the following criteria:

10. White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN.

Exclusion Criteria

• 1.Had prior exposure to apatinib or has known allegies to any of the excipients.

2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.

3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.

5.Imaging studies suggest that patients with tumors invading important blood vessels.

6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HR-HenanCH-OC019

Identifier Type: -

Identifier Source: org_study_id