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Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Primary Purpose

Ovarian Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cytoreductive surgery

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
Age ≥18 years
ECOG performance status ≤ 2
Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
1. absolute neutrophil count >1,500/mcL
2. platelets >100,000/mcL
3. total bilirubin ≤ 1.5 mg/dL
4. creatinine ≤ 1.5 mg/dL
5. AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
Patients must be > 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires >6 weeks
Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
Patients with known active CNS metastases
Patients with known hypersensitivity to any of the components of cisplatin
Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Women who are pregnant or nursing women
Patients with peripheral neuropathy ≥ grade 2
History of allogenic transplant
History of prior HIPEC or intraperitoneal chemotherapy
Known bulky extra-abdominopelvic disease
Patients with hearing impairment/tinnitus ≥ grade 2

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cytoreductive surgery

Arm Description

Outcomes

Primary Outcome Measures

To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Secondary Outcome Measures

Full Information

NCT ID

NCT05123807

First Posted

November 8, 2021

Last Updated

October 6, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05123807

Brief Title

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Official Title

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 7, 2022 (Actual)

Primary Completion Date

February 2, 2027 (Anticipated)

Study Completion Date

February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Detailed Description

PRIMARY OBJECTIVE: The primary objective is to estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer SECONDARY OBJECTIVES: To estimate overall survival (OS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer To evaluate toxicity and morbidity of secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer To estimate quality of life after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer To estimate what proportion of patients who preoperatively appear to be candidates for secondary cytoreductive surgery and HIPEC are found to have unresectable disease at time of surgical exploration To collect blood and tumor samples for biobanking to be used for exploratory endpoints

6. Conditions and Keywords

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

Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cytoreductive surgery

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Cytoreductive surgery

Intervention Description

(an operation to remove as much tumor tissue as possible) with hyperthermic intraperitoneal chemotherapy

Primary Outcome Measure Information:

Title

To estimate progression-free survival (PFS) after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer

Time Frame

through study completion, an average of 6 years (patients will be followed for 6 years after treatment completion

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer Age ≥18 years ECOG performance status ≤ 2 Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin ≤ 1.5 mg/dL creatinine ≤ 1.5 mg/dL AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal Patients must be > 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires >6 weeks Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative) Exclusion Criteria: Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin Patients with known active CNS metastases Patients with known hypersensitivity to any of the components of cisplatin Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or nursing women Patients with peripheral neuropathy ≥ grade 2 History of allogenic transplant History of prior HIPEC or intraperitoneal chemotherapy Known bulky extra-abdominopelvic disease Patients with hearing impairment/tinnitus ≥ grade 2

Central Contact Person:

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

Michael Frumovitz, MD

Phone

713-792-9599

mfrumovitz@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Frumovitz, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Frumovitz

Phone

713-792-9599

mfrumovitz@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Michael Frumovitz, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

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