Clinical trial NCT03942068: Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
Official title: Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-05-08
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ORR
timeFrame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Secondary outcomes:
measure: OS
timeFrame: through study completion, an average of 5 year
measure: PFS
timeFrame: through study completion, an average of 5 year
measure: DCR
timeFrame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Other outcomes:
Locations:
Study officials:
References: