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
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthermic Intraperitoneal Chemotherapy
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
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
No
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
Email
youzhy3@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Miaofang Wu
Phone
+8613828494674
Email
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
Email
wmiaofang@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After data publication
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A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel
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