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

M.D. Anderson Cancer Center

Status and phase

Enrolling

Phase 2

Conditions

Ovarian Cancer

Treatments

Other: Cytoreductive surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05123807

2021-0660

NCI-2021-12842 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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