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A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

Primary Purpose

Hyperthermic Intraperitoneal Chemotherapy

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Docetaxel

About this trial

This is an interventional treatment trial for Hyperthermic Intraperitoneal Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Sun Yat-sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel dose level

Arm Description

Initial dose of 60mg/m2 and increase the remaining dose gradient by 5 mg/m2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of DLT

Number of DLT cases at current dose/total cases at current dose

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

Full Information

NCT ID

NCT05410483

First Posted

May 31, 2022

Last Updated

June 6, 2022

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT05410483

Brief Title

A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Anticipated)

Study Completion Date

February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperthermic Intraperitoneal Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel dose level

Arm Type

Experimental

Arm Description

Initial dose of 60mg/m2 and increase the remaining dose gradient by 5 mg/m2

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Hyperthermic Intraperitoneal Docetaxel

Primary Outcome Measure Information:

Title

Maximum tolerated dose of docetaxel

Description

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.

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Incidence of DLT

Description

Number of DLT cases at current dose/total cases at current dose

Time Frame

9 weeks

Title

Effect of dose on tumor control rate

Description

The decrease of serum CA125 and HE4 concentrations and the results of imaging evaluation at different doses of docetaxel

Time Frame

9 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyao You

Phone

+8613725368618

youzhy3@mail2.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Miaofang Wu

Phone

+8613828494674

wmiaofang@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongqiu Lin

Organizational Affiliation

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen Memorial Hospital

City

Guangzhou

State/Province

Other (Non U.s.)

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

miaofang Wu

Phone

+8613828494674

wmiaofang@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

After data publication

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A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

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