Status:
UNKNOWN
A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Hyperthermic Intraperitoneal Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
This is a single-center study design, and 30 patients will be enrolled. Eligible patients will receive docetaxel at different dose levels according to the trial schedule.All the enrolled patients were...
Detailed Description
This is a single-center study design, and 30 patients will be enrolled. Eligible patients will receive docetaxel at different dose levels according to the trial schedule. All the enrolled patients wer...
Eligibility Criteria
Inclusion
- According to the gynecology malignant tumor abdominal hot perfusion chemotherapy clinical expert consensus, with HIPEC treatment indications, including the initial treatment of ovarian cancer, recurrent ovarian cancer, peritoneum pseudo myxoma, accompanied by abdominal cavity effusion or disseminated other gynecological malignant tumors of peritoneal cavity transfer, branch caused by malignant tumors refractory peritoneal effusion, Uterine sarcoma found after the use of tumor (uterine) device, ovarian mucous tumor before or during the rupture, a large amount of mucus overflow contamination of the abdominal cavity.
- Ages 18 to 70.
- Serum creatinine was within the normal range (reference range of creatinine: 58-96μmol/L) before receiving HIPEC, and renal function was normal.
- No bone marrow suppression before HIPEC (considering many factors affecting hemoglobin level, including intraoperative blood loss and postoperative fluid infusion hemodilution, hemoglobin ≥80g/L was set; Leukocyte ≥ 4.0\*109/L, granulocyte ≥ 2.0×109/L; Platelet ≥ 100×109/L).
- No abnormal liver function before receiving HIPEC (total bilirubin 3.4-22.2μmol/L, ALT 7-40 U/L, AST 13-35U/L, AST/ALT≤1.5).
- Signed informed consent and received docetaxel and cisplatin HIPEC treatment.
Exclusion
- Contraindications to HIPEC: intestinal obstruction; Extensive adhesion in peritoneal cavity; The abdominal cavity has obvious inflammation; There may be high risk factors for poor postoperative anastomotic healing, including anastomotic tissue edema, ischemia, obvious tension, severe hypoproteinemia, etc. Dysfunction of major organs such as heart, kidneys, liver and brain; Severe coagulopathy; Bile obstruction and ureteral obstruction.
- No history of radiotherapy or chemotherapy in recent 3 weeks.
- In addition to HIPEC, docetaxel and cisplatin should be used by other means within 3 weeks after HIPEC treatment.
- Those who have taken drugs that damage liver and kidney function or inhibit bone marrow within 3 months.
- Allergic to docetaxel and cisplatin.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05410483
Start Date
March 1 2022
End Date
February 1 2023
Last Update
June 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen Memorial Hospital
Guangzhou, Other (Non U.s.), China, 510000