A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

NCT05410483 | Unknown Phase 1 DMC

• 1 other identifier: 2022-KY-061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperthermic Intraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of DLT

  9 weeks

• Effect of dose on tumor control rate

  9 weeks

Study Arms (1)

Docetaxel dose level

EXPERIMENTAL

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

Drug: Docetaxel

Interventions

Docetaxel DRUG

Hyperthermic Intraperitoneal Docetaxel

Docetaxel dose level

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Other (Non U.s.), 510000, China

RECRUITING

Related Publications (1)

• You ZY, Wu MF, Li H, Ye YF, Wang LJ, Lin ZQ, Li J. A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer. J Gynecol Oncol. 2024 Jan;35(1):e1. doi: 10.3802/jgo.2024.35.e1. Epub 2023 Jul 5.

  PMID: 37477105 DERIVED

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Zhongqiu Lin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyao You

CONTACT

+8613725368618; youzhy3@mail2.sysu.edu.cn

Miaofang Wu

CONTACT

+8613828494674; wmiaofang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 8, 2022
• Study Start: March 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)