Overview

Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in Ovarian Cancer.

Status:
Not yet recruiting
Trial end date:
2024-02-23
Target enrollment:
0
Participant gender:
Female
Summary
Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborator:
CSPC Ouyi Pharmaceutical Co., Ltd.
Treatments:
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. Age :18-75years old;

2. Histopathological confirmed epithelial ovarian cancer/fallopian tube/peritoneal
cancer; Mucinous adenocarcinoma and low-grade serous carcinoma are excluded;

3. Recurrence more than 6 months after the last treatment with taxanes and platinum;
Relapse ≤ 3 times; Recovered from the toxicity of the previous chemotherapy to ≤ 1
(hair loss ≤ 2);

4. Relapse confirmed by imaging and CA125:

1. Clinically evaluable recurrent lesions. According to the RECIST 1.1 , there is at
least one measurable lesion as the target lesion. If the target lesion is a lymph
node, the shorter diameter is required to be greater than 1.5 cm, and the target
lesion has not received radiotherapy;

2. No clinically evaluable lesions:

i. Adenocarcinoma cells are confirmed by cytology in the pleural and ascites; ii.
Imaging considers that there is tumor recurrence, but the lesions do not meet the
measurable standard. They are all small lesions (longest diameter <10 mm or
pathological lymph node short diameter ≥10 mm to <15 mm). CA125 ≥ normal upper limit
(ULN) 2 times, and CA125 is still showing an upward trend after rechecking after 1
week; c) Patients with recurrence can receive a second cytoreductive surgery.
Postoperative R0 resection or residual tumor can be included in the group.

5. ECOG score 0-1;

6. Expected survival time ≥ 3 months;

7. Laboratory tests: absolute neutrophil count (ANC): ≥1.5×10^9/L; platelets
(PLT):≥100×10^9/L;hemoglobin (Hb): ≥90g/L (blood transfusions are allowed to meet or
maintain the targets);

8. Liver and renal function: aspartate aminotransferase (AST) and alanine
aminotransferase (ALT)≤ULN 2.5times, or metastasis; total bilirubin (TBil) level≤ ULN 1.5 times or ≤ ULN 2.5 times when the
patients have Gilbert's syndrome; Serum creatinine ≤ ULN 1.5 times or Calculated
creatinine clearance ≥ 50 mL/min;

9. 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.

10. Signed the informed consent.

Exclusion Criteria:

1. Patients who had previously received paclitaxel (albumin-bound);

2. Patients who have received abdominal or pelvic radiotherapy;

3. Patients with central nervous system disease or brain metastases;

4. Other malignancies have occurred within the last 5 years, except for cured cervical
carcinoma in situ, cutaneous squamous cell carcinoma or controlled basal cell
carcinoma of the skin;

5. Prior Grade ≥ 2 sensory or motor neuropathy;

6. 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.

7. Allergies to chemotherapeutic drugs or their excipients or intolerant patients;

8. Receive other anti-tumor drugs or participate in other anti-cancer treatment clinical
studies within 4 weeks of the first chemotherapy administration;

9. Severe infections occurred within 4 weeks before treatment, including but not limited
to infectious complications requiring hospitalization, bacteremia, or severe
pneumonia;

10. Human immunodeficiency virus (HIV) positive;

11. Hepatitis B surface antigen (HBsAg) positive. For patients with previous HBV infection
or HBV infection cured (the HBsAg is negative, but the total hepatitis B virus core
antibody [HBcAb] is positive), if HBV DNA is negative or Undetectable, they can
participate in this research;

12. Hepatitis C virus (HCV) antibody positive; Or human immunodeficiency virus and HCV RNA
test both positive;

13. Researchers think it is not suitable for enrolling.