A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

Hyperthermic Intraperitoneal Chemotherapy Clinical Trial

Official title:

A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel and Cisplatin in Patients Receiving Hyperthermic Intraperitoneal Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410483
• Other study ID #: 2022-KY-061
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Zhiyao You
• Phone: +8613725368618
• Email: youzhy3[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 treated with docetaxel during the first HIPEC treatment and cisplatin during the second HIPEC treatment at 43℃ for 1 hour.The dose of docetaxel for patients in the next group was determined according to the incidence of dose-limiting toxicity (DLT) of the previous docetaxel dose level. Finally, the maximum tolerated dose (MTD) of docetaxel for HIPEC was calculated according to the incidence of dose-limiting toxicity.

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 were treated with docetaxel during the first HIPEC treatment and cisplatin during the second HIPEC treatment at 43℃ for 1 hour. Four dosages of docetaxel were set up in the study. We decided to take the initial dose of 60mg/m2 and increase the remaining dose gradient by 5 mg/m2. The dosage of cisplatin was 75mg/m2. Time-to-event Bayesian Optimal Interval Design(TITE-BOIN) was used, with 3 patients as an observation group (i.e. a cohort), starting from a dose of 60mg/m2. The dose of docetaxel for patients in the next group was determined according to the incidence of dose-limiting toxicity (DLT) of the previous docetaxel dose level. Finally, the maximum tolerated dose (MTD) of docetaxel for HIPEC was calculated according to the incidence of dose-limiting toxicity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Ages 18 to 70.

3. Serum creatinine was within the normal range (reference range of creatinine:

58-96µmol/L) before receiving HIPEC, and renal function was normal.

4. 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).

5. 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).

6. Signed informed consent and received docetaxel and cisplatin HIPEC treatment.

Exclusion Criteria:

1. 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.

2. No history of radiotherapy or chemotherapy in recent 3 weeks.

3. In addition to HIPEC, docetaxel and cisplatin should be used by other means within 3 weeks after HIPEC treatment.

4. Those who have taken drugs that damage liver and kidney function or inhibit bone marrow within 3 months.

5. Allergic to docetaxel and cisplatin.

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Hyperthermic Intraperitoneal Chemotherapy

Intervention

Drug:
• Docetaxel
Hyperthermic Intraperitoneal Docetaxel

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of docetaxel	The MTD of docetaxel for abdominal thermal perfusion was calculated by observing the incidence of dose-limiting toxicity 3 weeks after the end of HIPEC.	21 days
Secondary	Incidence of DLT	Number of DLT cases at current dose/total cases at current dose	9 weeks
Secondary	Effect of dose on tumor control rate	The decrease of serum CA125 and HE4 concentrations and the results of imaging evaluation at different doses of docetaxel	9 weeks