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

Ovarian Cancer Clinical Trial

Official title:

Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03942068
• Other study ID #: HR-HenanCH-OC019
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2019
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor
• Apatinib
a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Secondary	OS	Overall Survival	through study completion, an average of 5 year
Secondary	PFS	Progression-Free Survival	through study completion, an average of 5 year
Secondary	DCR	Disease Control Rate	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months